Left atrial appendage occlusion devices

ABSTRACT

An occlusion device (210) is provided for occluding a left atrial appendage (LAA), including a compliant balloon (230) defining a fluid-tight balloon chamber (232), and an actuating shaft (234), which is disposed at least partially within the balloon chamber (232) for setting a distance between distal and proximal end portions (236, 238) of the balloon (230). A proximal LAA-orifice cover (70) includes a frame (72) and a covering (74) fixed to the frame (72). An orifice-support stent (290) is fixed to and extends distally from the proximal LAA-orifice cover (70), and is generally cylindrical when in a radially-expanded state. Other embodiments are also described.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application claims priority from U.S. ProvisionalApplication 62/906,393, filed Sep. 26, 2019, which is assigned to theassignee of the present application and incorporated herein byreference.

FIELD OF THE APPLICATION

The present invention generally relates to an occlusion device foroccluding a left atrial appendage.

BACKGROUND OF THE APPLICATION

The left atrial appendage (LAA) is a cavity that presents in the leftatrium of the heart. In patients with atrial fibrillation, the passageand steadiness of blood within this cavity can cause thrombus formation,which increases the risk of stroke. Percutaneous LAA occlusion is atherapy for the prevention of stroke in patients with atrialfibrillation. LAA occlusion is used as an alternative to, or incombination with, oral anticoagulant therapy. LAA occlusion hasfavorable clinical outcomes, but commercially-available devices aretypically self-expandable, and not designed to adapt to the LAA anatomy,and thus sometimes result in complications or suboptimal outcomes. Inthese environments, some of the currently available occlusion devicesare limited by the poor adaptability of the device to the defect (lackof conformability) and by a lack of intra-device sealing (due to thehigh-flow environment).

PCT Publication WO 2019/057950 to Maisano et al. describes an occluderdevice for occluding a cardiovascular defect or a gap between a medicaldevice and adjacent body tissue, including a compliant balloon defininga fluid-tight balloon chamber and provided with a balloon channelforming a longitudinal passage from a proximal side to a distal side ofthe balloon; a tip element disposed at the distal side of the balloon, abase element disposed at the proximal side of the balloon, andconnecting means comprising at least one connecting strut attached tothe tip element and to the base element, the tip element and the baseelement each having a guide opening substantially coaxial to the balloonchannel for slidingly receiving therein a guidewire for the device;elongated actuating means disposed longitudinally slidable in theballoon channel, releasably connectable to the tip element, andlongitudinally slidable with respect to the base element; locking meansfor maintaining a predetermined distance between the tip element and thebase element; and proximal connector means for releasably connecting theoccluder device to correspondingly configured distal connector means ofa catheter device. The balloon includes a fluid port for filling andunfitting a fluid into and from the balloon chamber. An occluder systemcomprises an occluder device and a catheter device cooperatingtherewith.

U.S. Pat. No. 6,652,556 to VanTassel et al. describes apparatus forpermanent placement across an ostium of a left atrial appendage in apatient, which includes a filtering membrane configured to extend acrossthe ostium of the left atrial appendage. The filtering membrane has apermeable structure which allows blood to flow through but substantiallyinhibits thrombus from passing therethrough. The apparatus also includesa support structure comprising a plurality of fingers which are radiallyoutwardly expandable with respect to a longitudinal axis to permanentlyengage the interior wall of the left atrial appendage. The filteringmembrane is attached to the support structure extending across theostium of the left atrial appendage.

SUMMARY OF THE APPLICATION

Some embodiments of the present invention provide occlusion devices formechanically occluding a left atrial appendage (LAA). The occlusiondevices comprise a compliant balloon defining a fluid-tight balloonchamber, and an actuating shaft, which is (a) disposed at leastpartially within the balloon chamber, (b) connected to a distal endportion of the balloon, and (c) longitudinally moveable with respect toa proximal end portion of the balloon so as to set a distance betweenthe distal and the proximal end portions of the balloon. The occlusiondevices also comprise a valve, which can be closed after inflation ofthe balloon chamber.

The shape and compliancy of the occlusion devices, optionally includingplastic deformation of struts thereof, enable anchoring of the occlusiondevices and sealing of the LAA while allowing for conformation andadaptation to the geometrical attributes of the LAA, thereby filling thespace of the LAA at least to a certain extent, regardless of theparticular morphological type of the LAA.

In addition, delivery systems are provided that enable over-the-wireengagement to the LAA, the adjustment of the length and orientation ofthe occlusion devices during deployment, and the inflation of theballoon chamber with saline or another filling liquid.

The occlusion devices described herein are designed to be delivered intothe LAA while longitudinally extended, and either entirely or partiallycompressed. After delivery, the occlusion devices are adapted to thelanding zone anatomy by inflating the balloon chamber and shortening thelongitudinal dimension of struts arranged between proximal and distalend portions of the balloon. Under the influence of internal pressurefrom inflation, the balloon chamber assumes a certain volume which, fora given longitudinal balloon dimension, results in a certain lateral orradial dimension, which provides a good seal between the balloon and theadjacent anatomy of the LAA. Changing the longitudinal balloondimension, by selecting a different distance between the distal andproximal end portions of the balloon, results in a corresponding changein the radial or lateral extension of the balloon. In other words,shortening the distance between the distal and proximal end portions ofthe balloon results in a corresponding increase in radial or lateralextension under otherwise constant conditions, which improves the sealwith the adjacent tissue of the LAA and inhibits unwanted blood passage.The lateral extension of the balloon is not necessarily symmetric,either because the balloon is not necessarily symmetric and/or becausethe anatomy against which the balloon is laterally expanded may causeasymmetric balloon expansion. The radial or lateral expansion togetherinclude within their scope one or more directions generallyperpendicular to the longitudinal axis of the balloon.

In the context of the present disclosure, the terms “distal” and“proximal” are used accordingly to their standard meaning in the fieldof percutaneous cardiovascular devices. The term “proximal” refers tothose components of the device assembly which, when following a deliverycatheter during percutaneous delivery, are closer to the end of thecatheter that is configured for manipulation by the user (e.g., acatheter handle manipulated by a physician). The term “distal” is usedto refer to those components of the device assembly that are moredistant from the end of the catheter that is configured for manipulationby the user and/or that are inserted farther into the body of a patient.

The term “compliant” used herein in relation with balloons or withstructural components implies a deformability that substantially followsan applied force. Accordingly, a “compliant balloon” means a balloonwhich progressively expands under the effect of increasing radialpressure as long as a certain burst pressure is not exceeded.

As used herein, the term “strut” means an elongate structural elementwhich can be formed, e.g., a thin wire, rod, or thick-walled tube, allof which do not necessarily have a circular cross section.

There is therefore provided, in accordance with an Inventive Concept 1of the present invention, an occlusion device for occluding a leftatrial appendage (LAA), the occlusion device for use with a deliverysystem, the occlusion device including:

a compliant balloon defining a fluid-tight balloon chamber;

an actuating shaft, which is (a) disposed at least partially within theballoon chamber, (b) connected to a distal end portion of the balloon,and (c) longitudinally moveable with respect to a proximal end portionof the balloon so as to set a distance between the distal and theproximal end portions of the balloon;

a proximal LAA-orifice cover, which (a) is configured to assume aradially-compressed state and a radially-expanded state, (b) includes aframe and a covering fixed to the frame, and (c) when in theradially-expanded state, is generally orthogonal to the actuating shaftand has a greatest dimension, measured perpendicular to the actuatingshaft, of between 10 and 50 mm; and

an orifice-support stent, which (a) is fixed to and extends distallyfrom the proximal LAA-orifice cover, (b) is configured to assume aradially-compressed state and a radially-expanded state, and (c) isgenerally cylindrical when in the radially-expanded state.

Inventive Concept 2. The occlusion device according to Inventive Concept1, wherein the orifice-support stent, when in the radially-expandedstate, has (i) a greatest dimension, measured perpendicular to theactuating shaft, of between 8 and 50 mm, and (ii) an axial length ofbetween 4 and 30 mm.Inventive Concept 3. The occlusion device according to Inventive Concept1, wherein the occlusion device further includes a distal tip disposedat the distal end portion of the balloon, wherein the actuating shaft isconnected to the distal tip.Inventive Concept 4. The occlusion device according to Inventive Concept1, wherein the actuating shaft is shaped so as to define, at least inpart, a distal tip disposed at the distal end portion of the balloon.Inventive Concept 5. The occlusion device according to Inventive Concept1, wherein the occlusion device further includes a proximal basedisposed at the proximal end portion of the balloon, wherein theactuating shaft is moveable with respect to the proximal base.Inventive Concept 6. The occlusion device according to Inventive Concept1, for use with a guidewire, wherein the actuating shaft is shaped so asto define a guidewire lumen for slidingly receiving therein theguidewire.Inventive Concept 7. The occlusion device according to Inventive Concept1, wherein the compliant balloon includes a compliant material selectedfrom the group consisting of: polycaprolactone (PCL), polyglycolic acid(PGA), polylactic acid (PLA), and polydioxanone (PDO or PDS), silicone,polyurethane, polytetrafluoroethylene (PTFE), polymethylmethacrylate,polyether ether ketone (PEEK), polyvinyl chloride, polyethyleneterephthalate, nylon, polyamide, polyamide, and polyether block amide(PEBA).Inventive Concept 8. The occlusion device according to any one ofInventive Concepts 1-7, wherein the orifice-support stent is not fixedto the balloon, such that a shape of the balloon can changeindependently of a shape of the orifice-support stent.Inventive Concept 9. The occlusion device according to any one ofInventive Concepts 1-7, wherein the occlusion device is configured suchthat inflation of the balloon chamber transitions the orifice-supportstent from its radially-compressed state to its radially-expanded state.Inventive Concept 10. The occlusion device according to any one ofInventive Concepts 1-7,

wherein the occlusion device further includes a proximal tube, which isaxially fixed with respect to the proximal end portion of the balloon,and

wherein the proximal LAA-orifice cover is fixed to the proximal tuberadially surrounding the proximal tube, and is indirectly connected tothe balloon via the proximal tube and is not directly connected to theballoon.

Inventive Concept 11. The occlusion device according to InventiveConcept 10, wherein the actuating shaft is slidably disposed partiallywithin the proximal tube.Inventive Concept 12. The occlusion device according to any one ofInventive Concepts 1-7, wherein the occlusion device further includesconnecting struts fixed to the distal end portion of the balloon and tothe proximal end portion of the balloon.Inventive Concept 13. The occlusion device according to InventiveConcept 12, wherein the occlusion device is configured such thatinflation of the balloon chamber plastically deforms the connectingstruts.Inventive Concept 14. The occlusion device according to InventiveConcept 12, wherein the occlusion device is configured such thatshortening of the balloon plastically deforms the connecting struts.Inventive Concept 15. The occlusion device according to any one ofInventive Concepts 1-7, wherein the balloon has an average wallthickness of between 100 and 5000 microns.Inventive Concept 16. The occlusion device according to any one ofInventive Concepts 1-7, wherein the balloon has, at a thinnest portionof a wall of the balloon, a thinnest wall thickness of between 20 and500 microns.Inventive Concept 17. An occlusion system including the occlusion deviceaccording to any one of Inventive Concepts 1-7, the occlusion systemfurther including an implant catheter, in which the occlusion device isreleasably disposed in a radially-compressed state, in which a greatestdistance between the proximal end portion of the balloon and the distalend portion of the balloon is between 8 and 80 mm.Inventive Concept 18. The occlusion device according to any one ofInventive Concepts 1-7, further including a valve.Inventive Concept 19. The occlusion device according to InventiveConcept 18,

wherein the occlusion device is shaped so as to define a fluid flowpath, and

wherein the valve is configured to selectively allow or block fluid flowbetween the fluid flow path and the balloon chamber when the valve is inopen and closed states, respectively.

Inventive Concept 20. The occlusion device according to InventiveConcept 19,

wherein the occlusion device is shaped so as to define the fluid flowpath along a portion of the actuating shaft,

wherein the occlusion device further includes a locking mechanism, whichis configured to assume locked and unlocked states, and which isconfigured, when in the locked state, to maintain, between the distalend portion of the balloon and the proximal end portion of the balloon,the distance set using the actuating shaft, and

wherein the occlusion device is configured such that reduction of thedistance, by proximal longitudinal movement of the actuating shaft:

-   -   (a) to a first predetermined distance between the distal and the        proximal end portions of the balloon automatically transitions        the valve from the open state to the closed state, and    -   (b) to a second predetermined distance between the distal and        the proximal end portions of the balloon automatically        transitions the locking mechanism from the unlocked state to the        locked state.        Inventive Concept 21. The occlusion device according to        Inventive Concept 20, wherein the occlusion device is configured        to be releasably connected to the delivery system, and wherein        the occlusion device is configured such that the fluid flow path        is coupled in fluid communication with the delivery system when        the occlusion device is releasably connected to the delivery        system.        Inventive Concept 22. The occlusion device according to        Inventive Concept 1, wherein the occlusion device further        includes a proximal connector that is configured to releasably        connect the occlusion device to a correspondingly configured        distal connector of the delivery system.        Inventive Concept 23. The occlusion device according to        Inventive Concept 22, wherein the proximal connector is shaped        so as to define a thread.        Inventive Concept 24. An occlusion system including the        occlusion device according to any one of Inventive Concepts        22-23, the occlusion system for use with a guidewire and further        including the delivery system cooperating therewith, the        delivery system including an implant catheter connected to an        operating handle, the implant catheter including a longitudinal        passageway for the guidewire, a distal connector for releasably        connecting the implant catheter to the correspondingly        configured proximal connector of the occlusion device, and an        inflation tube channel releasably connectable to the fluid flow        path of the occlusion device.

There is further provided, in accordance with an Inventive Concept 25 ofthe present invention, an occlusion device for occluding a left atrialappendage (LAA), the occlusion device for use with a delivery system,the occlusion device including:

a compliant balloon defining a fluid-tight balloon chamber;

an actuating shaft, which is (a) disposed at least partially within theballoon chamber, (b) connected to a distal end portion of the balloon,and (c) longitudinally moveable with respect to a proximal end portionof the balloon so as to set a distance between the distal and theproximal end portions of the balloon;

a locking mechanism, which is configured to assume locked and unlockedstates, and which is configured, when in the locked state, to maintain,between the distal end portion of the balloon and the proximal endportion of the balloon, the distance set using the actuating shaft; and

a valve,

wherein the occlusion device is shaped so as to define a fluid flow pathalong a portion of the actuating shaft,

wherein the valve is configured to selectively allow or block fluid flowbetween the fluid flow path and the balloon chamber when the valve is inopen and closed states, respectively, and

wherein the occlusion device is configured such that reduction of thedistance, by proximal longitudinal movement of the actuating shaft:

-   -   (a) to a first predetermined distance between the distal and the        proximal end portions of the balloon automatically transitions        the valve from the open state to the closed state, and    -   (b) to a second predetermined distance between the distal and        the proximal end portions of the balloon automatically        transitions the locking mechanism from the unlocked state to the        locked state.        Inventive Concept 26. The occlusion device according to        Inventive Concept 25, wherein the first predetermined distance        does not equal the second predetermined distance.        Inventive Concept 27. The occlusion device according to        Inventive Concept 26, wherein the first predetermined distance        is less than the second predetermined distance.        Inventive Concept 28. The occlusion device according to        Inventive Concept 25, wherein the first predetermined distance        equals the second predetermined distance.        Inventive Concept 29. The occlusion device according to        Inventive Concept 25, wherein the occlusion device is configured        to be releasably connected to the delivery system, and wherein        the occlusion device is configured such that the fluid flow path        is coupled in fluid communication with the delivery system when        the occlusion device is releasably connected to the delivery        system.        Inventive Concept 30. The occlusion device according to        Inventive Concept 25, wherein the occlusion device further        includes a distal tip disposed at the distal end portion of the        balloon, wherein the actuating shaft is connected to the distal        tip.        Inventive Concept 31. The occlusion device according to        Inventive Concept 25, wherein the actuating shaft is shaped so        as to define, at least in part, a distal tip disposed at the        distal end portion of the balloon.        Inventive Concept 32. The occlusion device according to        Inventive Concept 25, wherein the occlusion device further        includes a proximal base disposed at the proximal end portion of        the balloon, wherein the actuating shaft is moveable with        respect to the proximal base.        Inventive Concept 33. The occlusion device according to        Inventive Concept 25, for use with a guidewire, wherein the        actuating shaft is shaped so as to define a guidewire lumen for        slidingly receiving therein the guidewire.        Inventive Concept 34. The occlusion device according to        Inventive Concept 25, wherein the compliant balloon includes a        compliant material selected from the group consisting of:        polycaprolactone (PCL), polyglycolic acid (PGA), polylactic acid        (PLA), and polydioxanone (PDO or PDS), silicone, polyurethane,        polytetrafluoroethylene (PTFE), polymethylmethacrylate,        polyether ether ketone (PEEK), polyvinyl chloride, polyethylene        terephthalate, nylon, polyamide, polyamide, and polyether block        amide (PEBA).        Inventive Concept 35. The occlusion device according to any one        of Inventive Concepts 25-34, wherein the occlusion device is        shaped so as to define the fluid flow path alongside the portion        of the actuating shaft.        Inventive Concept 36. The occlusion device according to any one        of Inventive Concepts 25-34, wherein the valve is disposed along        the actuating shaft.        Inventive Concept 37. The occlusion device according to any one        of Inventive Concepts 25-34, wherein the occlusion device        further includes a proximal tube, which is axially fixed with        respect to the proximal end portion of the balloon, wherein the        actuating shaft is slidably disposed partially within the        proximal tube.        Inventive Concept 38. The occlusion device according to        Inventive Concept 37, wherein the occlusion device is shaped so        as to define the fluid flow path along the portion of the        actuating shaft radially between an external surface of the        actuating shaft and an internal surface of the proximal tube.        Inventive Concept 39. The occlusion device according to        Inventive Concept 38, wherein the valve is disposed along the        actuating shaft.        Inventive Concept 40. The occlusion device according to        Inventive Concept 39, wherein the valve includes a seal around        at least a portion of the external surface of the actuating        shaft, and wherein the valve is configured to assume the open        state when the seal is disposed at one or more first axial        positions with respect to the proximal tube, and the closed        state when the seal is disposed at one or more second axial        positions with respect to the proximal tube, the one or more        second axial positions proximal to the one or more first axial        positions.        Inventive Concept 41. The occlusion device according to        Inventive Concept 40, wherein the seal, the actuating shaft, and        the proximal tube are arranged such that the seal blocks fluid        flow out of a distal end of the proximal tube at least when the        seal is disposed at the one or more first axial positions with        respect to the proximal tube.        Inventive Concept 42. The occlusion device according to        Inventive Concept 38, wherein a wall of the proximal tube is        shaped so as to define one or more tabs through the wall,        wherein the one or more tabs are biased to flex radially inward,        and wherein, when the valve is in the open state, the fluid flow        path passes through the wall between respective proximal ends of        the one or more tabs and a non-tabbed portion of the wall        axially adjacent the one or more tabs.        Inventive Concept 43. The occlusion device according to        Inventive Concept 42, wherein the non-tabbed portion of the wall        is disposed proximal to the one or more tabs.        Inventive Concept 44. The occlusion device according to        Inventive Concept 42, wherein the external surface of the        actuating shaft is shaped so as to define one or more        protrusions around at least a portion of the actuating shaft,        and wherein the proximal ends of the one or more tabs are shaped        so as to prevent distal movement of the one or more protrusions        when the one or more protrusions are disposed proximal to the        proximal ends of the one or more tabs, thereby causing the        locking mechanism to assume the locked state.        Inventive Concept 45. The occlusion device according to        Inventive Concept 37, wherein the occlusion device further        includes a proximal LAA-orifice cover, which (a) is fixed to the        proximal tube radially surrounding the proximal tube, (b) is        configured to assume a radially-compressed state and a        radially-expanded state, (c) includes a frame and a covering        fixed to the frame, (d) when in the radially-expanded state, is        generally orthogonal to the proximal tube and has a greatest        dimension, measured perpendicular to the proximal tube, of        between 10 and 50 mm, and (e) is indirectly connected to the        balloon via the proximal tube and is not directly connected to        the balloon.        Inventive Concept 46. The occlusion device according to        Inventive Concept 45, wherein the occlusion device further        includes an orifice-support stent, which (a) is fixed to and        extends distally from the proximal LAA-orifice cover, (b) is        configured to assume a radially-compressed state and a        radially-expanded state, and (c) is generally cylindrical when        in the radially-expanded state.        Inventive Concept 47. The occlusion device according to        Inventive Concept 46, wherein the orifice-support stent, when in        the radially-expanded state, has (i) a greatest dimension,        measured perpendicular to the actuating shaft, of between 8 and        50 mm, and (ii) an axial length of between 4 and 30 mm.        Inventive Concept 48. The occlusion device according to any one        of Inventive Concepts 25-34, wherein the occlusion device        further includes connecting struts fixed to the distal end        portion of the balloon and to the proximal end portion of the        balloon.        Inventive Concept 49. The occlusion device according to        Inventive Concept 48, wherein the occlusion device is configured        such that inflation of the balloon chamber plastically deforms        the connecting struts.        Inventive Concept 50. The occlusion device according to        Inventive Concept 48, wherein the occlusion device is configured        such that shortening of the balloon plastically deforms the        connecting struts.        Inventive Concept 51. The occlusion device according to any one        of Inventive Concepts 25-34, wherein the balloon has an average        wall thickness of between 100 and 5000 microns.        Inventive Concept 52. The occlusion device according to any one        of Inventive Concepts 25-34, wherein the balloon has, at a        thinnest portion of a wall of the balloon, a thinnest wall        thickness of between 20 and 500 microns.        Inventive Concept 53. An occlusion system including the        occlusion device according to any one of Inventive Concepts        25-34, the occlusion system further including an implant        catheter, in which the occlusion device is releasably disposed        in a radially-compressed state, in which a greatest distance        between the proximal end portion of the balloon and the distal        end portion of the balloon is between 8 and 80 mm.        Inventive Concept 54. The occlusion device according to any one        of Inventive Concepts 25-34, wherein the occlusion device        further includes a proximal connector that is configured to        releasably connect the occlusion device to a correspondingly        configured distal connector of the delivery system.        Inventive Concept 55. The occlusion device according to        Inventive Concept 54, wherein the proximal connector is shaped        so as to define a thread.        Inventive Concept 56. An occlusion system including the        occlusion device according to any one of Inventive Concepts        25-34, the occlusion system for use with a guidewire and further        including the delivery system cooperating therewith, the        delivery system including an implant catheter connected to an        operating handle, the implant catheter including a longitudinal        passageway for the guidewire, a distal connector for releasably        connecting the implant catheter to the correspondingly        configured proximal connector of the occlusion device, and an        inflation tube channel releasably connectable to the fluid flow        path of the occlusion device.

There is still further provided, in accordance with an Inventive Concept57 of the present invention, an occlusion device for occluding a leftatrial appendage (LAA), the occlusion device for use with a deliverysystem, the occlusion device including:

a compliant balloon defining a fluid-tight balloon chamber;

an actuating shaft, which is (a) disposed at least partially within theballoon chamber, (b) connected to a distal end portion of the balloon,and (c) longitudinally moveable with respect to a proximal end portionof the balloon so as to set a distance between the distal and theproximal end portions of the balloon; and

connecting struts fixed to the distal end portion of the balloon and tothe proximal end portion of the balloon, wherein the connecting strutsinclude:

-   -   first lateral portions arranged along a lateral surface of the        balloon,    -   second distal-end portions arranged on a distal surface of the        balloon,    -   third proximal-end portions arranged on a proximal surface of        the balloon, and    -   distal end portions that join the second distal-end portions of        the struts to the distal end portion of the balloon,        respectively, and have a serpentine shape, wherein the occlusion        device is configured such that upon inflation of the balloon        chamber, the distal end portions are curved.        Inventive Concept 58. The occlusion device according to        Inventive Concept 57, wherein the connecting struts include        proximal end portions that join the third proximal-end portions        of the struts to the proximal end portion of the balloon,        respectively, and have a serpentine shape, and wherein the        occlusion device is configured such that upon inflation of the        balloon chamber, the proximal end portions are curved.        Inventive Concept 59. The occlusion device according to        Inventive Concept 57, wherein the connecting struts include        distal interface portions that join the first lateral portions        and the second distal-end portions, respectively, and have a        serpentine shape, and wherein the occlusion device is configured        such that upon inflation of the balloon chamber, the distal        interface portions are curved.        Inventive Concept 60. The occlusion device according to        Inventive Concept 57, wherein the connecting struts include        proximal interface portions that join the first lateral portions        and the third proximal-end portions, respectively, and have a        serpentine shape, and wherein the occlusion device is configured        such that upon inflation of the balloon chamber, the proximal        interface portions are curved.        Inventive Concept 61. The occlusion device according to        Inventive Concept 57, wherein the first lateral portions of the        struts are generally straight.        Inventive Concept 62. The occlusion device according to        Inventive Concept 57, wherein the second distal-end portions and        the third proximal-end portions are generally straight.        Inventive Concept 63. The occlusion device according to        Inventive Concept 57, wherein the first lateral portions of the        struts are generally straight, and the second distal-end        portions and the third proximal-end portions are generally        straight.        Inventive Concept 64. The occlusion device according to        Inventive Concept 57, wherein the occlusion device is configured        such that inflation of the balloon chamber plastically deforms        the connecting struts.        Inventive Concept 65. The occlusion device according to        Inventive Concept 57, wherein the occlusion device is configured        such that shortening of the balloon plastically deforms the        connecting struts.        Inventive Concept 66. The occlusion device according to any one        of Inventive Concepts 57-65,

wherein the distal interface portions are shaped so as to definerespective pairs of parallel serpentine struts that define respectivenarrow elongate gaps therebetween, and

wherein the struts are shaped so as to define a plurality of spikes,which:

-   -   extend from outer ends of the second distal-end portions,        respectively,    -   are disposed in the respective narrow elongate gaps, generally        axially oriented, when the balloon is in a non-inflated,        elongate configuration, and    -   are configured to extend more radially upon inflation of the        balloon chamber to serve as tissue-engaging barbs.        Inventive Concept 67. The occlusion device according to any one        of Inventive Concepts 57-65, wherein the connecting struts        further include closed stent cells that connect adjacent pairs        of the first lateral portions.        Inventive Concept 68. The occlusion device according to        Inventive Concept 67, wherein two or more of the closed stent        cells arranged in series connect the adjacent pairs of the first        lateral portions.        Inventive Concept 69. The occlusion device according to        Inventive Concept 67, wherein the closed stent cells are shaped        as respective rhombuses.        Inventive Concept 70. The occlusion device according to        Inventive Concept 67, wherein the first lateral portions are        oriented parallel to a central longitudinal axis of the        occlusion device.        Inventive Concept 71. The occlusion device according to        Inventive Concept 67, wherein an average width of the struts of        first lateral portions equals at least 200% of an average width        of the struts of the closed stent cells.

There is additionally provided, in accordance with an Inventive Concept72 of the present invention, an occlusion device for occluding a leftatrial appendage (LAA), the occlusion device for use with a deliverysystem, the occlusion device including:

a compliant balloon defining a fluid-tight balloon chamber;

an actuating shaft, which is (a) disposed at least partially within theballoon chamber, (b) connected to a distal end portion of the balloon,and (c) longitudinally moveable with respect to a proximal end portionof the balloon so as to set a distance between the distal and theproximal end portions of the balloon; and

connecting struts fixed to the distal end portion of the balloon and tothe proximal end portion of the balloon, wherein the connecting strutsinclude:

-   -   first lateral portions arranged along a lateral surface of the        balloon,    -   second distal-end portions arranged on a distal surface of the        balloon,    -   third proximal-end portions arranged on a proximal surface of        the balloon, and    -   distal interface portions that join the first lateral portions        and the second distal-end portions, respectively, and have a        serpentine shape, wherein the occlusion device is configured        such that upon inflation of the balloon chamber, the distal        interface portions are curved.        Inventive Concept 73. The occlusion device according to        Inventive Concept 72, wherein the connecting struts include        proximal interface portions that join the first lateral portions        and the third proximal-end portions, respectively, and have a        serpentine shape, and wherein the occlusion device is configured        such that upon inflation of the balloon chamber, the proximal        interface portions are curved.        Inventive Concept 74. The occlusion device according to        Inventive Concept 72, wherein the first lateral portions of the        struts are generally straight.        Inventive Concept 75. The occlusion device according to        Inventive Concept 72, wherein the second distal-end portions and        the third proximal-end portions are generally straight.        Inventive Concept 76. The occlusion device according to        Inventive Concept 72, wherein the first lateral portions of the        struts are generally straight, and the second distal-end        portions and the third proximal-end portions are generally        straight.        Inventive Concept 77. The occlusion device according to        Inventive Concept 72, wherein the occlusion device is configured        such that inflation of the balloon chamber plastically deforms        the connecting struts.        Inventive Concept 78. The occlusion device according to        Inventive Concept 72, wherein the occlusion device is configured        such that shortening of the balloon plastically deforms the        connecting struts.        Inventive Concept 79. The occlusion device according to        Inventive Concept 72, wherein the connecting struts include        distal end portions that join the second distal-end portions of        the struts to the distal end portion of the balloon,        respectively, and have a serpentine shape, and wherein the        occlusion device is configured such that upon inflation of the        balloon chamber, the distal end portions are curved.        Inventive Concept 80. The occlusion device according to        Inventive Concept 72, wherein the connecting struts include        proximal end portions that join the third proximal-end portions        of the struts to the proximal end portion of the balloon,        respectively, and have a serpentine shape, and wherein the        occlusion device is configured such that upon inflation of the        balloon chamber, the proximal end portions are curved.        Inventive Concept 81. The occlusion device according to any one        of Inventive Concepts 72-80,

wherein the distal interface portions are shaped so as to definerespective pairs of parallel serpentine struts that define respectivenarrow elongate gaps therebetween, and

wherein the struts are shaped so as to define a plurality of spikes,which:

-   -   extend from outer ends of the second distal-end portions,        respectively,    -   are disposed in the respective narrow elongate gaps, generally        axially oriented, when the balloon is in a non-inflated,        elongate configuration, and    -   are configured to extend more radially upon inflation of the        balloon chamber to serve as tissue-engaging barbs.        Inventive Concept 82. The occlusion device according to any one        of Inventive Concepts 72-80, wherein the connecting struts        further include closed stent cells that connect adjacent pairs        of the first lateral portions.        Inventive Concept 83. The occlusion device according to        Inventive Concept 82, wherein two or more of the closed stent        cells arranged in series connect the adjacent pairs of the first        lateral portions.        Inventive Concept 84. The occlusion device according to        Inventive Concept 82, wherein the closed stent cells are shaped        as respective rhombuses.        Inventive Concept 85. The occlusion device according to        Inventive Concept 82, wherein the first lateral portions are        oriented parallel to a central longitudinal axis of the        occlusion device.        Inventive Concept 86. The occlusion device according to        Inventive Concept 82, wherein an average width of the struts of        first lateral portions equals at least 200% of an average width        of the struts of the closed stent cells.

There is yet additionally provided, in accordance with an InventiveConcept 87 of the present invention, an occlusion device for occluding aleft atrial appendage (LAA), the occlusion device for use with adelivery system, the occlusion device including:

a compliant balloon defining a fluid-tight balloon chamber;

an actuating shaft, which is (a) disposed at least partially within theballoon chamber, (b) connected to a distal end portion of the balloon,and (c) longitudinally moveable with respect to a proximal end portionof the balloon so as to set a distance between the distal and theproximal end portions of the balloon; and

connecting struts fixed to the distal end portion of the balloon and tothe proximal end portion of the balloon, wherein the connecting strutsinclude:

-   -   first lateral portions arranged along a lateral surface of the        balloon, and    -   closed stent cells that connect adjacent pairs of the first        lateral portions.        Inventive Concept 88. The occlusion device according to        Inventive Concept 87, wherein two or more of the closed stent        cells arranged in series connect the adjacent pairs of the first        lateral portions.        Inventive Concept 89. The occlusion device according to        Inventive Concept 87, wherein the closed stent cells are shaped        as respective rhombuses.        Inventive Concept 90. The occlusion device according to        Inventive Concept 87, wherein the first lateral portions are        oriented parallel to a central longitudinal axis of the        occlusion device.        Inventive Concept 91. The occlusion device according to        Inventive Concept 87, wherein an average width of the struts of        first lateral portions equals at least 200% of an average width        of the struts of the closed stent cells.

There is also provided, in accordance with an Inventive Concept 92 ofthe present invention, a method for occluding a left atrial appendage(LAA) of a patient, the method including:

using a delivery system, positioning:

-   -   a compliant balloon of an occlusion device in a longitudinally        extended form thereof in the LAA,    -   an actuating shaft of the occlusion device in the LAA, wherein        the actuating shaft is (a) disposed at least partially within        the balloon chamber, (b) connected to a distal end portion of        the balloon, and (c) longitudinally moveable with respect to a        proximal end portion of the balloon so as to set a distance        between the distal and the proximal end portions of the balloon,    -   a proximal LAA-orifice cover in a left atrium outside the LAA,        against an atrial wall surrounding an orifice of the LAA,        wherein the proximal LAA-orifice cover is (a) configured to        assume a radially-compressed state and a radially-expanded        state, (b) includes a frame and a covering fixed to the frame,        and (c) when in the radially-expanded state, is generally        orthogonal to the actuating shaft and has a greatest dimension,        measured perpendicular to the actuating shaft, of between 10 and        50 mm, and    -   an orifice-support stent at least partially in the LAA, wherein        the orifice-support stent is (a) fixed to and extending distally        from the proximal LAA-orifice cover, (b) configured to assume a        radially-compressed state and a radially-expanded state, and (c)        generally cylindrical when in the radially-expanded state;

inflating the compliant balloon by filling, via a fluid flow path alonga portion of the actuating shaft, a fluid into the balloon chamber;

expanding the balloon in a radial or a lateral direction by shorteningthe distance between the distal and the proximal end portions of theballoon to a desired distance; and

releasing the occlusion device from the delivery system.

Inventive Concept 93. The method according to Inventive Concept 92,wherein the orifice-support stent is not fixed to the balloon, such thata shape of the balloon can change independently of a shape of theorifice-support stent.Inventive Concept 94. The method according to Inventive Concept 92,wherein inflating the compliant balloon transitions the orifice-supportstent from its radially-compressed state to its radially-expanded state.

There is further provided, in accordance with an Inventive Concept 95 ofthe present invention, a method for occluding a left atrial appendage(LAA) of a patient, the method including:

using a delivery system, positioning a compliant balloon of an occlusiondevice in a longitudinally extended form thereof in the LAA;

inflating the compliant balloon by filling, via a fluid flow path alonga portion of an actuating shaft of the occlusion device, a fluid into afluid-tight balloon chamber defined by the balloon, while a valve of theocclusion device in an open state in which the valve allows fluid flowbetween the fluid flow path and the balloon chamber, wherein theactuating shaft is (a) disposed at least partially within the balloonchamber, (b) connected to a distal end portion of the balloon, and (c)longitudinally moveable with respect to a proximal end portion of theballoon so as to set a distance between the distal and the proximal endportions of the balloon;

expanding the balloon in a radial or a lateral direction by shorteningthe distance between the distal and the proximal end portions of theballoon to a desired distance, by proximally longitudinally moving theactuating shaft:

-   -   (a) to a first predetermined distance between the distal and the        proximal end portions of the balloon, which automatically        transitions the valve from the open state to a closed state in        which the valve blocks fluid flow between the fluid flow path        and the balloon chamber, and    -   (b) to a second predetermined distance between the distal and        the proximal end portions of the balloon, which automatically        transitions a locking mechanism from an unlocked state to a        locked state, in which the locking mechanism maintains, between        the distal end portion of the balloon and the proximal end        portion of the balloon, the distance set using the actuating        shaft; and releasing the occlusion device from the delivery        system.        Inventive Concept 96. The method according to Inventive Concept        95, wherein positioning the balloon in the LAA includes:

advancing a guidewire into a body of the patient using the deliverysystem; and

advancing the occlusion device over the guidewire.

Inventive Concept 97. The method according to Inventive Concept 95,wherein the first predetermined distance does not equal the secondpredetermined distance.Inventive Concept 98. The method according to Inventive Concept 97,wherein the first predetermined distance is less than the secondpredetermined distance.Inventive Concept 99. The method according to Inventive Concept 95,wherein the first predetermined distance equals the second predetermineddistance.Inventive Concept 100. The method according to Inventive Concept 95,wherein the occlusion device is shaped so as to define the fluid flowpath alongside the portion of the actuating shaft.Inventive Concept 101. The method according to Inventive Concept 95,wherein the valve is disposed along the actuating shaft.Inventive Concept 102. The method according to Inventive Concept 95,wherein the occlusion device further includes a proximal tube, which isaxially fixed with respect to the proximal end portion of the balloon,wherein the actuating shaft is slidably disposed partially within theproximal tube.Inventive Concept 103. The method according to Inventive Concept 102,wherein the occlusion device is shaped so as to define the fluid flowpath along the portion of the actuating shaft radially between anexternal surface of the actuating shaft and an internal surface of theproximal tube.Inventive Concept 104. The method according to Inventive Concept 103,wherein the valve is disposed along the actuating shaft.Inventive Concept 105. The method according to Inventive Concept 104,wherein the valve includes a seal around at least a portion of theexternal surface of the actuating shaft, and wherein the valve isconfigured to assume the open state when the seal is disposed at one ormore first axial positions with respect to the proximal tube, and theclosed state when the seal is disposed at one or more second axialpositions with respect to the proximal tube, the one or more secondaxial positions proximal to the one or more first axial positions.Inventive Concept 106. The method according to Inventive Concept 105,wherein the seal, the actuating shaft, and the proximal tube arearranged such that the seal blocks fluid flow out of a distal end of theproximal tube at least when the seal is disposed at the one or morefirst axial positions with respect to the proximal tube.Inventive Concept 107. The method according to Inventive Concept 103,wherein a wall of the proximal tube is shaped so as to define one ormore tabs through the wall, wherein the one or more tabs are biased toflex radially inward, and wherein, when the valve is in the open state,the fluid flow path passes through the wall between respective proximalends of the one or more tabs and a non-tabbed portion of the wallaxially adjacent the one or more tabs.Inventive Concept 108. The method according to Inventive Concept 107,wherein the non-tabbed portion of the wall is disposed proximal to theone or more tabs.Inventive Concept 109. The method according to Inventive Concept 107,wherein the external surface of the actuating shaft is shaped so as todefine one or more protrusions around at least a portion of theactuating shaft, and wherein the proximal ends of the one or more tabsare shaped so as to prevent distal movement of the one or moreprotrusions when the one or more protrusions are disposed proximal tothe proximal ends of the one or more tabs, thereby causing the lockingmechanism to assume the locked state.Inventive Concept 110. The method according to Inventive Concept 102,wherein the occlusion device further includes a proximal LAA-orificecover, which (a) is fixed to the proximal tube radially surrounding theproximal tube, (b) is configured to assume a radially-compressed stateand a radially-expanded state, (c) includes a frame and a covering fixedto the frame, (d) when in the radially-expanded state, is generallyorthogonal to the proximal tube and has a greatest dimension, measuredperpendicular to the proximal tube, of between 10 and 50 mm, and (e) isindirectly connected to the balloon via the proximal tube and is notdirectly connected to the balloon.Inventive Concept 111. The method according to Inventive Concept 110,wherein the occlusion device further includes an orifice-support stent,which (a) is fixed to and extends distally from the proximal LAA-orificecover, (b) is configured to assume a radially-compressed state and aradially-expanded state, and (c) is generally cylindrical when in theradially-expanded state.Inventive Concept 112. The method according to Inventive Concept 111,wherein the orifice-support stent, when in the radially-expanded state,has (i) a greatest dimension, measured perpendicular to the actuatingshaft, of between 8 and 50 mm, and (ii) an axial length of between 4 and30 mm.Inventive Concept 113. The method according to Inventive Concept 95,wherein the occlusion device further includes connecting struts fixed tothe distal end portion of the balloon and to the proximal end portion ofthe balloon.Inventive Concept 114. The method according to Inventive Concept 113,wherein the occlusion device is configured such that inflation of theballoon chamber plastically deforms the connecting struts.Inventive Concept 115. The method according to Inventive Concept 113,wherein the occlusion device is configured such that shortening of theballoon plastically deforms the connecting struts.

There is still further provided, in accordance with an Inventive Concept116 of the present invention, apparatus for occluding a left atrialappendage (LAA), the apparatus including:

(i) an occlusion device, including:

-   -   a compliant balloon defining a fluid-tight balloon chamber;    -   an actuating shaft, which is (a) disposed at least partially        within the balloon chamber, (b) connected to a distal end        portion of the balloon, and (c) longitudinally moveable with        respect to a proximal end portion of the balloon so as to set a        distance between the distal and the proximal end portions of the        balloon; and    -   a valve, including an elastomer sleeve that surrounds a portion        of the actuating shaft,    -   wherein the occlusion device is shaped so as to define a fluid        flow path having one or more fluid-flow-path openings to the        balloon chamber, and    -   wherein the elastomer sleeve is configured to have a resting        state in which the sleeve covers and seals the one or more        fluid-flow-path openings, such that the valve is in a closed        state; and

(ii) a delivery system, which is configured to be releasably connectedto the occlusion device, and which includes a valve-opening prop, whichis configured:

-   -   (a) when in a propping position, to prop open and deform the        elastomer sleeve such that the elastomer sleeve does not seal        the one or more fluid-flow-path openings and the valve is in an        open state, and    -   (b) when in a non-propping position, not to prop open the        elastomer sleeve, such that elastomer sleeve assumes the resting        state and the valve is in the closed state.        Inventive Concept 117. The apparatus according to Inventive        Concept 116, wherein the valve-opening prop includes one or more        tabs that extend radially outward from an axis of the elastomer        sleeve, so as to prop open the elastomer sleeve.        Inventive Concept 118. The apparatus according to Inventive        Concept 116, wherein the valve-opening prop is configured such        that axial sliding thereof with respect to the elastomer sleeve        transitions the valve-opening prop from the propping position to        the non-propping position.        Inventive Concept 119. The apparatus according to Inventive        Concept 116, wherein the occlusion device further includes a        locking mechanism, which is configured to assume locked and        unlocked states, and which is configured, when in the locked        state, to maintain, between the distal end portion of the        balloon and the proximal end portion of the balloon, the        distance set using the actuating shaft.        Inventive Concept 120. The apparatus according to Inventive        Concept 116, wherein the occlusion device is configured to be        releasably connected to the delivery system, and wherein the        occlusion device is configured such that the fluid flow path is        coupled in fluid communication with the delivery system when the        occlusion device is releasably connected to the delivery system.        Inventive Concept 121. The apparatus according to Inventive        Concept 116, wherein the occlusion device further includes a        distal tip disposed at the distal end portion of the balloon,        wherein the actuating shaft is connected to the distal tip.        Inventive Concept 122. The apparatus according to Inventive        Concept 116, wherein the actuating shaft is shaped so as to        define, at least in part, a distal tip disposed at the distal        end portion of the balloon.        Inventive Concept 123. The apparatus according to Inventive        Concept 116, wherein the occlusion device further includes a        proximal base disposed at the proximal end portion of the        balloon, wherein the actuating shaft is longitudinally moveable        with respect to the proximal base.        Inventive Concept 124. The apparatus according to Inventive        Concept 116, for use with a guidewire, wherein the actuating        shaft is shaped so as to define a guidewire lumen for slidingly        receiving therein the guidewire.        Inventive Concept 125. The apparatus according to Inventive        Concept 116, wherein the compliant balloon includes a compliant        material selected from the group consisting of: polycaprolactone        (PCL), polyglycolic acid (PGA), polylactic acid (PLA), and        polydioxanone (PDO or PDS), silicone, polyurethane,        polytetrafluoroethylene (PTFE), polymethylmethacrylate,        polyether ether ketone (PEEK), polyvinyl chloride, polyethylene        terephthalate, nylon, polyamide, polyamide, and polyether block        amide (PEBA).        Inventive Concept 126. The apparatus according to any one of        Inventive Concepts 116-125, wherein the occlusion device further        includes a proximal tube, which is axially fixed with respect to        the proximal end portion of the balloon.        Inventive Concept 127. The apparatus according to Inventive        Concept 126, wherein the actuating shaft is slidably disposed        partially within the proximal tube.        Inventive Concept 128. The apparatus according to Inventive        Concept 118, wherein the valve-opening prop includes a tubular        portion, which is disposed at least partially within the        proximal tube.        Inventive Concept 129. The apparatus according to Inventive        Concept 128, wherein the valve-opening prop includes one or more        tabs that extend (a) axially away from the tubular portion        and (b) radially outward from the proximal tube, so as to prop        open the elastomer sleeve.        Inventive Concept 130. The apparatus according to Inventive        Concept 129, wherein the one or more tabs pass through at least        a portion of the one or more fluid-flow-path openings when the        valve-opening prop is in the propping position.        Inventive Concept 131. The apparatus according to Inventive        Concept 129, wherein the proximal tube is shaped so as to define        one or more access openings through a wall of the proximal tube,        and wherein the one or more tabs pass through the one or more        access openings at least when the valve-opening prop is in the        propping position.        Inventive Concept 132. The apparatus according to Inventive        Concept 126, wherein the occlusion device further includes a        proximal LAA-orifice cover, which (a) is fixed to the proximal        tube radially surrounding the proximal tube, (b) is configured        to assume a radially-compressed state and a radially-expanded        state, (c) includes a frame and a covering fixed to the        frame, (d) when in the radially-expanded state, is generally        orthogonal to the proximal tube and has a greatest dimension,        measured perpendicular to the proximal tube, of between 10 and        50 mm, and (e) is indirectly connected to the balloon via the        proximal tube and is not directly connected to the balloon.        Inventive Concept 133. The apparatus according to Inventive        Concept 132, wherein the occlusion device further includes an        orifice-support stent, which (a) is fixed to and extends        distally from the proximal LAA-orifice cover, (b) is configured        to assume a radially-compressed state and a radially-expanded        state, and (c) is generally cylindrical when in the        radially-expanded state.        Inventive Concept 134. The apparatus according to Inventive        Concept 133, wherein the orifice-support stent, when in the        radially-expanded state, has (i) a greatest dimension, measured        perpendicular to the actuating shaft, of between 8 and 50 mm,        and (ii) an axial length of between 4 and 30 mm.        Inventive Concept 135. The apparatus according to any one of        Inventive Concepts 116-125, wherein the occlusion device further        includes connecting struts fixed to the distal end portion of        the balloon and to the proximal end portion of the balloon.        Inventive Concept 136. The apparatus according to Inventive        Concept 135, wherein the occlusion device is configured such        that inflation of the balloon chamber plastically deforms the        connecting struts.        Inventive Concept 137. The apparatus according to Inventive        Concept 135, wherein the occlusion device is configured such        that shortening of the balloon plastically deforms the        connecting struts.        Inventive Concept 138. The apparatus according to any one of        Inventive Concepts 116-125, wherein the balloon has an average        wall thickness of between 100 and 5000 microns.        Inventive Concept 139. The apparatus according to any one of        Inventive Concepts 116-125, wherein the balloon has, at a        thinnest portion of a wall of the balloon, a thinnest wall        thickness of between 20 and 500 microns.        Inventive Concept 140. The apparatus according to any one of        Inventive Concepts 116-125, wherein the delivery system further        including an implant catheter, in which the occlusion device is        releasably disposed in a radially-compressed state, in which a        greatest distance between the proximal end portion of the        balloon and the distal end portion of the balloon is between 8        and 80 mm.        Inventive Concept 141. The apparatus according to any one of        Inventive Concepts 116-125, wherein the occlusion device further        includes a proximal connector that is configured to releasably        connect the occlusion device to a correspondingly configured        distal connector of the delivery system.        Inventive Concept 142. The apparatus according to Inventive        Concept 141, wherein the proximal connector is shaped so as to        define a thread.        Inventive Concept 143. The apparatus according to any one of        Inventive Concepts 116-125, for use with a guidewire, wherein        the delivery system includes an implant catheter connected to an        operating handle, the implant catheter including a longitudinal        passageway for the guidewire, a distal connector for releasably        connecting the implant catheter to the correspondingly        configured proximal connector of the occlusion device, and an        inflation tube channel releasably connectable to the fluid flow        path of the occlusion device.

There is additionally provided, in accordance with an Inventive Concept144 of the present invention, apparatus for occluding a left atrialappendage (LAA), the apparatus including:

(i) an occlusion device, including:

-   -   a compliant balloon defining a fluid-tight balloon chamber;    -   an actuating shaft, which is (a) disposed at least partially        within the balloon chamber, (b) connected to a distal end        portion of the balloon, and (c) longitudinally moveable with        respect to a proximal end portion of the balloon so as to set a        distance between the distal and the proximal end portions of the        balloon; and    -   a valve, including an elastomer sleeve that surrounds a portion        of the actuating shaft,    -   wherein the occlusion device is shaped so as to define a fluid        flow path having one or more fluid-flow-path openings to the        balloon chamber, and    -   wherein the elastomer sleeve is configured to have a resting        state in which the sleeve covers and seals the one or more        fluid-flow-path openings, such that the valve is in a closed        state; and

(ii) a delivery system, which is configured to be releasably connectedto the occlusion device, and which includes one or more guidewires,which:

-   -   (a) when in a propping position, prop open and deform the        elastomer sleeve such that the elastomer sleeve does not seal        the one or more fluid-flow-path openings and the valve is in an        open state, and    -   (b) when in a non-propping position, do not prop open the        elastomer sleeve, such that elastomer sleeve assumes the resting        state and the valve is in the closed state.        Inventive Concept 145. The apparatus according to Inventive        Concept 144, wherein the one or more guidewires pass through at        least a portion of the one or more fluid-flow-path openings when        the one or more guidewires are in the propping position.        Inventive Concept 146. The apparatus according to any one of        Inventive Concepts 144-145, wherein the occlusion device further        includes a proximal tube, which is axially fixed with respect to        the proximal end portion of the balloon.        Inventive Concept 147. The apparatus according to Inventive        Concept 146, wherein the actuating shaft is slidably disposed        partially within the proximal tube.        Inventive Concept 148. The apparatus according to Inventive        Concept 146, wherein the occlusion device further includes a        proximal LAA-orifice cover, which (a) is fixed to the proximal        tube radially surrounding the proximal tube, (b) is configured        to assume a radially-compressed state and a radially-expanded        state, (c) includes a frame and a covering fixed to the        frame, (d) when in the radially-expanded state, is generally        orthogonal to the proximal tube and has a greatest dimension,        measured perpendicular to the proximal tube, of between 10 and        50 mm, and (e) is indirectly connected to the balloon via the        proximal tube and is not directly connected to the balloon.        Inventive Concept 149. The apparatus according to Inventive        Concept 148, wherein the occlusion device further includes an        orifice-support stent, which (a) is fixed to and extends        distally from the proximal LAA-orifice cover, (b) is configured        to assume a radially-compressed state and a radially-expanded        state, and (c) is generally cylindrical when in the        radially-expanded state.        Inventive Concept 150. The apparatus according to Inventive        Concept 149, wherein the orifice-support stent, when in the        radially-expanded state, has (i) a greatest dimension, measured        perpendicular to the actuating shaft, of between 8 and 50 mm,        and (ii) an axial length of between 4 and 30 mm.

There is yet additionally provided, in accordance with an InventiveConcept 151 of the present invention, apparatus for occluding a leftatrial appendage (LAA), the apparatus including:

(i) an occlusion device, including:

-   -   a compliant balloon defining a fluid-tight balloon chamber;    -   a proximal tube, which is axially fixed with respect to a        proximal end portion of the balloon; and    -   a spring, which is (a) disposed at least partially within the        balloon chamber, (b) connected to a distal end portion of the        balloon and the proximal tube, and (c) has a relaxed length,        wherein when the spring has the relaxed length, the distal end        portion of the balloon is at a relaxed distance from the        proximal end portion of the balloon; and

(ii) a delivery system, which is configured to be releasably connectedto the occlusion device, and which includes a stylet, which is removablydisposed through the proximal tube and within the spring, wherein theocclusion device is configured such that a degree of distal advancementof the stylet within the spring sets a tensed length of the spring,which in turn sets a tensed distance between the distal and the proximalend portions of the balloon, the tensed distance greater than therelaxed distance.

Inventive Concept 152. The apparatus according to Inventive Concept 151,wherein the occlusion device further includes a valve.Inventive Concept 153. The apparatus according to Inventive Concept 152,

wherein the occlusion device is shaped so as to define a fluid flowpath, and

wherein the valve is configured to selectively allow or block fluid flowbetween the fluid flow path and the balloon chamber when the valve is inopen and closed states, respectively.

Inventive Concept 154. The apparatus according to Inventive Concept 151,wherein the occlusion device further includes a distal tip disposed atthe distal end portion of the balloon, wherein the spring is connectedto the distal tip.Inventive Concept 155. The apparatus according to Inventive Concept 151,wherein the compliant balloon includes a compliant material selectedfrom the group consisting of: polycaprolactone (PCL), polyglycolic acid(PGA), polylactic acid (PLA), and polydioxanone (PDO or PDS), silicone,polyurethane, polytetrafluoroethylene (PTFE), polymethylmethacrylate,polyether ether ketone (PEEK), polyvinyl chloride, polyethyleneterephthalate, nylon, polyamide, polyamide, and polyether block amide(PEBA).Inventive Concept 156. The apparatus according to any one of InventiveConcepts 151-155,

wherein the occlusion device includes an occlusion-device connector,which is connected to the distal end portion of the balloon and isshaped so as to define an occlusion-device connection interface, and

wherein the stylet includes a stylet connector, which is disposed at adistal end of the stylet and is shaped so as to define a styletconnection interface that is reversibly couplable to theocclusion-device connection interface.

Inventive Concept 157. The apparatus according to Inventive Concept 156,wherein the occlusion-device connection interface and the styletconnection interface are shaped so as to define respective threads.Inventive Concept 158. The apparatus according to any one of InventiveConcepts 151-155, wherein the occlusion device further includes aproximal LAA-orifice cover, which (a) is fixed to the proximal tuberadially surrounding the proximal tube, (b) is configured to assume aradially-compressed state and a radially-expanded state, (c) includes aframe and a covering fixed to the frame, (d) when in theradially-expanded state, is generally orthogonal to the proximal tubeand has a greatest dimension, measured perpendicular to the proximaltube, of between 10 and 50 mm, and (e) is indirectly connected to theballoon via the proximal tube and is not directly connected to theballoon.Inventive Concept 159. The apparatus according to Inventive Concept 158,wherein the occlusion device further includes an orifice-support stent,which (a) is fixed to and extends distally from the proximal LAA-orificecover, (b) is configured to assume a radially-compressed state and aradially-expanded state, and (c) is generally cylindrical when in theradially-expanded state.Inventive Concept 160. The apparatus according to Inventive Concept 159,wherein the orifice-support stent, when in the radially-expanded state,has (i) a greatest dimension, measured perpendicular to the proximaltube, of between 8 and 50 mm, and (ii) an axial length of between 4 and30 mm.Inventive Concept 161. The apparatus according to any one of InventiveConcepts 151-155, wherein the occlusion device further includesconnecting struts fixed to the distal end portion of the balloon and tothe proximal end portion of the balloon.Inventive Concept 162. The apparatus according to Inventive Concept 161,wherein the occlusion device is configured such that inflation of theballoon chamber plastically deforms the connecting struts.Inventive Concept 163. The apparatus according to Inventive Concept 161,wherein the occlusion device is configured such that shortening of theballoon plastically deforms the connecting struts.Inventive Concept 164. The apparatus according to any one of InventiveConcepts 151-155, wherein the balloon has an average wall thickness ofbetween 100 and 5000 microns.Inventive Concept 165. The apparatus according to any one of InventiveConcepts 151-155, wherein the balloon has, at a thinnest portion of awall of the balloon, a thinnest wall thickness of between 20 and 500microns.Inventive Concept 166. The apparatus according to any one of InventiveConcepts 151-155, wherein the delivery system further includes animplant catheter, in which the occlusion device is releasably disposedin a radially-compressed state, in which a greatest distance between theproximal end portion of the balloon and the distal end portion of theballoon is between 8 and 80 mm.Inventive Concept 167. The apparatus according to Inventive Concept 151,wherein the occlusion device further includes a proximal connector thatis configured to releasably connect the occlusion device to acorrespondingly configured distal connector of the delivery system.Inventive Concept 168. The apparatus according to Inventive Concept 167,wherein the proximal connector is shaped so as to define a thread.Inventive Concept 169. The apparatus according to any one of InventiveConcepts 167-168, for use with a guidewire, wherein the delivery systemfurther includes an implant catheter connected to an operating handle,the implant catheter including a longitudinal passageway for theguidewire, a distal connector for releasably connecting the implantcatheter to the correspondingly configured proximal connector of theocclusion device, and an inflation tube channel releasably connectableto the fluid flow path of the occlusion device.

There is also provided, in accordance with an Inventive Concept 170 ofthe present invention, a method for occluding a left atrial appendage(LAA) of a patient, the method including:

using a delivery system, positioning a compliant balloon of an occlusiondevice in a longitudinally extended form thereof in the LAA;

inflating the compliant balloon by filling a fluid into a fluid-tightballoon chamber defined by the balloon, via a fluid flow path having oneor more fluid-flow-path openings to the balloon chamber, while avalve-opening prop of the delivery system is in a propping position inwhich the valve-opening prop props open and deforms an elastomer sleeveof a valve of the occlusion device, such that the elastomer sleeve doesnot seal the one or more fluid-flow-path openings and the valve is in anopen state, wherein the elastomer sleeve surrounds a portion of anactuating shaft of the occlusion device, the actuating shaft (a)disposed at least partially within the balloon chamber, (b) connected toa distal end portion of the balloon, and (c) longitudinally moveablewith respect to a proximal end portion of the balloon so as to set adistance between the distal and the proximal end portions of theballoon;

transitioning the valve-opening prop to a non-propping position, inwhich the valve-opening prop does not prop open the elastomer sleeve,such that elastomer sleeve assumes a resting state in which the sleevecovers and seals the one or more fluid-flow-path openings, such that thevalve is in a closed state; and

releasing the occlusion device from the delivery system.

There is further provided, in accordance with an Inventive Concept 171of the present invention, a method for occluding a left atrial appendage(LAA) of a patient, the method including:

using a delivery system, positioning a compliant balloon of an occlusiondevice in a longitudinally extended form thereof in the LAA;

inflating the compliant balloon by filling a fluid into a fluid-tightballoon chamber defined by the balloon, via a fluid flow path having oneor more fluid-flow-path openings to the balloon chamber, while one ormore guidewires of the delivery system are in a propping position, inwhich the one or more guidewires prop open and deform an elastomersleeve of a valve of the occlusion device such that the elastomer sleevedoes not seal the one or more fluid-flow-path openings and the valve isin an open state, wherein the elastomer sleeve surrounds a portion of anactuating shaft that is (a) disposed at least partially within theballoon chamber, (b) connected to a distal end portion of the balloon,and (c) longitudinally moveable with respect to a proximal end portionof the balloon so as to set a distance between the distal and theproximal end portions of the balloon;

transitioning the one or more guidewires to a non-propping position, inwhich the one or more guidewires do not prop open the elastomer sleeve,such that elastomer sleeve assumes a resting state in which the sleevecovers and seals the one or more fluid-flow-path openings, such that thevalve is in a closed state; and

releasing the occlusion device from the delivery system.

The present invention will be more fully understood from the followingdetailed description of embodiments thereof, taken together with thedrawings, in which:

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a schematic illustration of an occlusion device for occludinga left atrial appendage (LAA), in accordance with an application of thepresent invention;

FIGS. 2A-B are schematic cross-sectional illustrations of the occlusiondevice of FIG. 1 and a distal portion of a delivery system, inaccordance with an application of the present invention;

FIGS. 3A-F are schematic illustrations of steps of a method of deployingthe occlusion device of FIG. 1 using the delivery system of FIG. 2, inaccordance with an application of the present invention;

FIGS. 4A-C are schematic cross-sectional views of a portion of the stepsof the method shown in FIGS. 3A-F, in accordance with an application ofthe present invention;

FIG. 5 is a schematic illustration of the occlusion device of FIG. 1implanted to occlude an LAA, in accordance with an application of thepresent invention;

FIG. 6 is a schematic illustration of another occlusion device foroccluding an LAA, in accordance with an application of the presentinvention;

FIGS. 7A-C are schematic cross-sectional illustrations of the occlusiondevice of FIG. 6 and a distal portion of a delivery system, inaccordance with an application of the present invention;

FIG. 7D is a schematic illustration of another occlusion device foroccluding an LAA, in accordance with an application of the presentinvention;

FIG. 8 is a schematic illustration of yet another occlusion device foroccluding an LAA, in accordance with an application of the presentinvention;

FIGS. 9A-B are schematic cross-sectional illustrations of the occlusiondevice of FIG. 8 and a distal portion of a delivery system, inaccordance with an application of the present invention;

FIG. 10 is a schematic illustration of still another occlusion devicefor occluding an LAA, in accordance with an application of the presentinvention;

FIG. 11 is a schematic cross-sectional illustration of the occlusiondevice of FIG. 10 and a distal portion of a delivery system, inaccordance with an application of the present invention;

FIGS. 12A-B are schematic illustrations of another occlusion device foroccluding an LAA, partially deployed, in accordance with an applicationof the present invention;

FIGS. 13A-B are schematic illustrations of the occlusion device of FIGS.12A-B upon partial inflation of a balloon chamber thereof, in accordancewith an application of the present invention; and

FIGS. 14A-B are schematic illustrations of the occlusion device of FIGS.12A-B upon final inflation of a balloon chamber thereof, in accordancewith an application of the present invention.

DETAILED DESCRIPTION OF APPLICATIONS

FIG. 1 is a schematic illustration of an occlusion device 10 foroccluding a left atrial appendage (LAA), in accordance with anapplication of the present invention. Occlusion device 10 is for usewith a delivery system 20, which is described in more detail hereinbelowwith reference to FIGS. 3A-F. Delivery system 20 and the other deliverysystems described herein are typically transcatheter delivery systemsthat enable percutaneous deployment of the occlusion devices.

Reference is also made to FIGS. 2A-B, which are schematiccross-sectional illustrations of occlusion device 10 and a distalportion of delivery system 20, in accordance with an application of thepresent invention. FIG. 2A shows occlusion device 10 with a lockingmechanism 40 thereof in an unlocked state and valve 42 thereof in anopen state, as described hereinbelow. FIG. 2B shows occlusion device 10with locking mechanism 40 in a locked state and valve 42 in a closedstate, as described hereinbelow.

For some applications, occlusion device 10 comprises:

-   -   a compliant balloon 30 defining a fluid-tight balloon chamber        32;    -   an actuating shaft 34, which is (a) disposed at least partially        within balloon chamber 32, (b) connected to a distal end portion        36 of balloon 30, and (c) longitudinally moveable with respect        to a proximal end portion 38 of balloon 30 so as to set a        distance between distal and proximal end portions 36 and 38 of        balloon 30;    -   locking mechanism 40, which is configured to assume locked and        unlocked states, as shown in FIGS. 2B and 2A, respectively; and    -   a valve 42.

Occlusion device 10 is configured such that proximally longitudinallymoving actuating shaft 34 expands balloon 30 in a radial or a lateraldirection by shortening the distance between distal and proximal endportions 36 and 38 of balloon 30 to a desired distance.

Locking mechanism 40 is configured, when in the locked state, tomaintain, between distal end portion 36 of balloon 30 and proximal endportion 38 of balloon 30, the distance set using actuating shaft 34.

For some applications, occlusion device 10 is shaped so as to define afluid flow path 44 along (e.g., alongside, as shown) a portion ofactuating shaft 34. Valve 42 is configured to selectively:

-   -   allow fluid flow between fluid flow path 44 and balloon chamber        32 when valve 42 is in the open state, as shown in FIG. 2A, or    -   block fluid flow between fluid flow path 44 and balloon chamber        32 when valve 42 is in the closed state, as shown in FIG. 2B.

For some applications, occlusion device 10 is configured such thatreduction of the distance, by proximal longitudinal movement ofactuating shaft 34:

-   -   to a first predetermined distance between distal and proximal        end portions 36 and 38 of balloon 30 automatically transitions        valve 42 from the open state to the closed state, as shown in        the transition from FIG. 2A to FIG. 2B, and    -   to a second predetermined distance between distal and proximal        end portions 36 and 38 of balloon 30 automatically transitions        locking mechanism 40 from the unlocked state to the locked        state, as also shown in the transition from FIG. 2A to FIG. 2B.

For some applications, the first predetermined distance does not equalthe second predetermined distance. For example, the first predetermineddistance may be less than the second predetermined distance, such thatthe proximal longitudinal movement of actuating shaft 34 firstautomatically transitions valve 42 from the open state to the closedstate and subsequently automatically transitions locking mechanism 40from the unlocked state to the locked state. Alternatively, the firstpredetermined distance may be greater than the second predetermineddistance, such that this sequence is reversed.

Further alternatively, for some applications, the first predetermineddistance equals the second predetermined distance, such that theproximal longitudinal movement of actuating shaft 34 simultaneouslyautomatically transitions valve 42 from the open state to the closedstate and automatically transitions locking mechanism 40 from theunlocked state to the locked state.

For some applications, in order to cause the above-mentioned proximallongitudinal movement of actuating shaft 34, delivery system 20comprises a pull shaft 46, which is releasably coupled a proximal endportion of actuating shaft 34. For example, a distal portion of pullshaft 46 may comprise a pull-shaft coupling 48, which may, for example,be shaped so as to define a thread that removably engages acorresponding thread defined by the proximal end portion of actuatingshaft 34. Rotation of pull shaft 46 disengages shaft coupling 48 fromthe corresponding thread defined by the proximal end portion ofactuating shaft 34.

Typically, occlusion device 10 is configured to be releasably connectedto delivery system 20. For some applications, occlusion device 10 isconfigured such that fluid flow path 44 is coupled in fluidcommunication with delivery system 20 when occlusion device 10 isreleasably connected to delivery system 20, such as shown in FIGS. 2A-B.

For some applications, actuating shaft 34 is shaped so as to define, atleast in part, a distal tip 50 disposed at distal end portion 36 ofballoon 30, as shown in FIGS. 1 and 2A-B.

For some other applications, occlusion device 10 further comprises adistal tip disposed at distal end portion 36 of balloon 30, andactuating shaft 34 is connected to the distal tip (configuration notshown).

Alternatively or additionally, for some applications, occlusion device10 further comprises a proximal base disposed at proximal end portion 38of balloon 30, and actuating shaft 34 is moveable (e.g., longitudinallyor rotationally) with respect to the proximal base (configuration notshown).

For some applications, valve 42 is disposed along actuating shaft 34,such as shown in FIGS. 2A-B.

For some applications, occlusion device 10 further comprises a proximaltube 52, which is axially fixed with respect to proximal end portion 38of balloon 30. Actuating shaft 34 is slidably disposed partially withinproximal tube 52, e.g., so as to indirectly connect actuating shaft 34to proximal end portion 38 via proximal tube 52. For some of theseapplications, occlusion device 10 is shaped so as to define fluid flowpath 44 along the portion of actuating shaft 34, radially between anexternal surface of actuating shaft 34 and an internal surface ofproximal tube 52, such as shown in FIGS. 2A-B. Optionally, valve 42 isdisposed along actuating shaft 34.

For some applications, valve 42 comprises a seal 54 around at least aportion of (e.g., entirely around) the external surface of actuatingshaft 34. Valve 42 is configured to assume (a) the open state when seal54 is disposed at one or more first axial positions 56A with respect toproximal tube 52 (one such first axial position is shown in FIG. 2A),and (b) the closed state when seal 54 is disposed at one or more secondaxial positions 56B with respect to proximal tube 52 (one such secondaxial position is shown in FIG. 2B). The one or more second axialpositions 56B are proximal to the one or more first axial positions 56A.For example, seal 54 may comprise an O-ring, as shown in FIGS. 2A-B,e.g., a single O-ring or a series of O-rings. Optionally, one or moreadditional seals 19, e.g., one or more O-rings, are provided to providefurther stabilization an alignment of the distal tube inside theproximal tube by friction.

For some applications, seal 54, actuating shaft 34, and proximal tube 52are arranged such that seal 54 blocks fluid flow out of a distal end 58of proximal tube 52, at least when seal 54 is disposed at the one ormore first axial positions 56A with respect to proximal tube 52, such asshown in FIG. 2A. Alternatively or additionally, friction between seal54 and the inner surface of proximal tube 52 increases structuralstability, and/or enables stepwise inflation/implantation.

For some applications, a wall of proximal tube 52 is shaped so as todefine one or more tabs 60 through the wall. The one or more tabs 60 arebiased to flex radially inward. When valve 42 is in the open state, asshown in FIG. 2A, fluid flow path 44 passes through the wall betweenrespective proximal ends 62 of the one or more tabs 60 and a non-tabbedportion 64 of the wall axially adjacent the one or more tabs 60, such asproximal to the one or more tabs 60, as shown.

For some applications, the external surface of actuating shaft 34 isshaped so as to define one or more protrusions 66 around at least aportion of (e.g., entirely around) actuating shaft 34. Proximal ends 62of the one or more tabs 60 are shaped so as to prevent distal movementof the one or more protrusions 66 when the one or more protrusions 66are disposed proximal to the proximal ends 62 of the one or more tabs60, such as shown in FIG. 2B, thereby causing locking mechanism 40 toassume the locked state.

For some applications, occlusion device 10 further comprises a proximalLAA-orifice cover 70, which:

-   -   is fixed to proximal tube 52 radially surrounding proximal tube        52,    -   is configured to assume a radially-compressed state, such as        shown in FIG. 3A, described hereinbelow, and a radially-expanded        state, such as shown in FIGS. 1 and 2A-B,    -   comprises frame 72 and a covering 74 fixed to frame 72,    -   when in the radially-expanded state, is generally orthogonal to        proximal tube 52 and has a greatest dimension, measured        perpendicular to proximal tube 52, of at least 10 mm (e.g., at        least 20 mm), no more than 50 mm (e.g., no more than 30 mm),        and/or between 10 and 50 mm (e.g., between 20 and 30 mm), and    -   is typically indirectly connected to balloon 30 via proximal        tube 52 and is not directly connected to balloon 30.

This indirect connection of proximal LAA-orifice cover 70 to balloon 30generally prevents an anodic reaction between the typicallysuper-elastic (e.g., Nitinol) material of frame 72 of proximalLAA-orifice cover 70 and the typically plastically deformable (e.g.,stainless steel) material of struts 80, described hereinbelow. Such areaction might have occurred if the two elements were instead welded orotherwise bonded together in contact with each other. (Connection of theelements via an independent and passive element, such as an internaltube or shaft, also does not cause such a reaction.) Alternatively,proximal LAA-orifice cover 70 is directly connected to balloon 30, suchas if frame 72 comprises a different plastically-deformable material,such as titanium.

For some applications, occlusion device 10 further comprisesorifice-support stent 290, described hereinbelow with reference to FIGS.8 and 9A-B.

For some applications, actuating shaft 34 is shaped so as to define aguidewire lumen 76 for slidingly receiving therein a guidewire and/orpassage of liquid injected under pressure, such as contrast mediainjected from the proximal handle of the delivery tool to the distal endof the occlusion device. Alternatively, for other applications,actuating shaft 34 is not shaped so as to define a guidewire lumen.

For some applications, compliant balloon 30 comprises a compliantmaterial selected from the group consisting of: polycaprolactone (PCL),polyglycolic acid (PGA), polylactic acid (PLA), and polydioxanone (PDOor PDS), silicone, polyurethane, polytetrafluoroethylene (PTFE),polymethylmethacrylate, polyether ether ketone (PEEK), polyvinylchloride, polyethylene terephthalate, nylon, polyamide, polyamide, andpolyether block amide (PEBA).

For some applications, balloon 30 has an average wall thickness ofbetween 100 and 5000 microns. Alternatively or additionally, for someapplications, balloon 30 has, at a thinnest portion of a wall of balloon30, a thinnest wall thickness of between 20 and 500 microns.

For some applications, occlusion device 10 further comprises connectingstruts 80 fixed to distal end portion 36 of balloon 30 and to proximalend portion 38 of balloon 30. Struts 80 may be disposed inside balloon30, outside balloon 30, or some inside and some outside balloon 30. Forsome applications, struts 80 are arranged as a frame. For someapplications, struts 80 are arranged in a cage-like arrangement.Typically, struts 80 comprise a plastically-deformable material, such asstainless steel or titanium. Typically, struts 80 help shape balloon 30as the balloon chamber is inflated and/or the balloon is shortened.

Typically, occlusion device 10 is configured such that inflation ofballoon chamber 32 plastically deforms connecting struts 80. For someapplications, occlusion device 10 is configured such that shortening ofballoon 30 plastically deforms connecting struts 80.

For some applications, struts 80 are configured such that inflation ofballoon chamber 32 primarily causes radial deformation of struts 80,rather than deformation of the struts in a distal or proximal direction.To this end, first lateral portions 81A of struts 80 arranged along alateral surface of balloon 30 may be more compliant than second endportions 81B of struts 80 arranged on a distal surface of balloon 30and/or on a proximal surface of balloon 30. For example, first lateralportions 81A may be thinner than second end portions 81B, as shown inFIG. 1, and/or first lateral portions 81A may be shaped to be morecompliant, e.g., have a serpentine (e.g., sinusoidal) shape, as shown.Typically, first lateral portions 81A are oriented parallel to a centrallongitudinal axis of occlusion device 10.

Reference is now made to FIGS. 3A-F, which are schematic illustrationsof steps of a method of deploying occlusion device 10 using deliverysystem 20, in accordance with an application of the present invention.

Reference is also made to FIGS. 4A-C, which are schematiccross-sectional views of a portion of the steps of the method shown inFIGS. 3A-F, in accordance with an application of the present invention.

FIG. 3A schematically shows occlusion device 10 releasably disposed in aradially-compressed state within a sheath 82 of delivery system 20.Typically, a greatest distance between proximal end portion 38 ofballoon 30 and distal end portion 36 of balloon 30 is at least 8 mm(e.g., at least 15 mm), no more than 80 mm (e.g. no more than 60 mm),and/or between 8 and 80 mm (e.g., between 15 and 60 mm), when occlusiondevice 10 is in this radially-compressed state.

For some applications, occlusion device 10 comprises a proximalconnector 84 that is configured to releasably connect occlusion device10 to a correspondingly configured distal connector 86 of deliverysystem 20.

For some applications, distal connector 86 comprises one or more legsthat engage one or more respective coupling sites (e.g., slots) ofproximal connector 84, such as perhaps best seen in FIGS. 4A-C. Forexample, the legs may be configured to biased radially outward when inan unconstrained, resting state, and may be held radially inwardengaging the coupling sites of proximal connector 84, such as by implantcatheter 88, as shown in FIG. 4A. Proximal withdrawal of implantcatheter 88 with respect to occlusion device 10 release the legs, asshown in FIG. 4B.

Alternatively, proximal connector 84 is shaped so as to define a thread(configuration not shown).

For some applications, delivery system 20 comprises an implant catheter88 that is connected to an operating handle (not shown). Implantcatheter 88 comprises (a) a longitudinal passageway for a guidewire, (b)distal connector 86 for releasably connecting implant catheter 88 tocorrespondingly configured proximal connector 84 of occlusion device 10,and (c) an inflation tube channel releasably connectable to fluid flowpath 44 of occlusion device 10. The longitudinal passageway mayalternatively or additionally be used to inject contrast media from thehandle to a distal opening of the inflation tube channel distally to theballoon.

FIG. 3B shows occlusion device 10 after sheath 82 has been proximallywithdrawn, thereby releasing occlusion device 10. FIG. 3B also showsproximal LAA-orifice cover 70 in its radially-expanded state. Typically,frame 72 of proximal LAA-orifice cover 70 comprises a shape-memorymemory, e.g., a super-elastic metal, which causes cover 70 toautomatically transition to the radially-expanded state upon releasefrom sheath 82. Balloon 30 remains in a non-inflated, elongateconfiguration at this stage of deployment.

Typically, a healthcare worker places the distal end of occlusion device10 into the LAA, using delivery system navigation.

As shown in FIGS. 3C-D, the healthcare worker inflates balloon chamber32. FIG. 3C shows occlusion device 10 upon partial inflation of balloonchamber 32, while FIG. 3D shows occlusion device 10 upon completeinflation of balloon chamber 32. Balloon 30 may be inflated by fillingballoon chamber 32 with any fluid, including but not limited to salinesolution (optionally comprising a contrast medium), blood (e.g.,autologous blood), foam, and/or a glue (e.g., a gel, a liquid polymerthat can change its proprieties to become rigid, or a hydrogel thatremains a gel or self-cures at body temperature).

For some applications, struts 80 are shaped so as to define a pluralityof spikes 89 that are initially generally axially oriented, as shown inFIG. 3C, and are configured to extend more radially upon expansion ofballoon 30 to serve as tissue-engaging barbs, as shown in FIG. 3D.

FIGS. 3E and 4A show occlusion device 10 after (a) valve 42 hastransitioned from the open state to the closed state, (b) actuatingshaft 34 has been proximally longitudinally moved to expand balloon 30in a radial or a lateral direction by shortening the distance betweendistal and proximal end portions 36 and 38 of balloon 30 to a desireddistance, and (c) locking mechanism 40 has transitioned from theunlocked state to the locked state, as described hereinabove withreference to FIGS. 2A-B. Typically, after balloon 30 has been finallyfilled, actuating shaft 34 is proximally longitudinally moved to expandballoon 30 in a radial or a lateral direction by shortening the distancebetween distal and proximal end portions 36 and 38 of balloon 30 to adesired distance. Proximal connector 84 of occlusion device 10 is stillreleasably connected to correspondingly configured distal connector 86of delivery system 20.

FIGS. 3F and 4B-C show occlusion device 10 after proximal connector 84of occlusion device 10 has been released from distal connector 86 ofdelivery system 20.

FIG. 4C also shows occlusion device 10 after pull shaft 46 has beendecoupled from the proximal end portion of actuating shaft 34, such asby rotating pull shaft 46 to unscrew it, as described hereinabove.

Reference is now made to FIG. 5, which is a schematic illustration ofocclusion device 10 implanted to occlude an LAA 100, in accordance withan application of the present invention. As can be seen, balloon 30 isdisposed within LAA 100, and proximal LAA-orifice cover 70 is disposedin a left atrium 102 outside LAA 100, against the atrial wallsurrounding the orifice of LAA 100, thereby creating a continuum withthe atrium at the LAA level. Typically, proximal LAA-orifice cover 70protrudes only minimally because of its relatively flat shape, so as notto interfere with blood flow and not to cause thrombosis. Typically,struts 80 provide most of the anchoring of occlusion device 10, andballoon 30 provides most of the sealing of the LAA. In addition, inconfigurations in which covering 74 of proximal LAA-orifice cover 70 isblood-impermeable, proximal LAA-orifice cover 70 provides additionalsealing of the LAA, primarily to inhibit creation of thrombi on theballoon surface at the orifice level.

For some applications, proximal LAA-orifice cover 70 is asymmetric aboutproximal tube 52, e.g., elliptical or with a radius greater in onedirection than in the perpendicular direction.

For some applications, proximal LAA-orifice cover 70 is configured tohave an adjustable greatest dimension measured perpendicular to proximaltube 52. For example, rotation of a proximal LAA-orifice cover 70adjustment mechanism may adjust the greatest dimension.

For some applications, covering 74 of proximal LAA-orifice cover 70 isblood-permeable, so as to serve as filter for the passage of blood inand out of the LAA. For other applications, covering 74 is notblood-permeable, so as to create a secondary sealing of the LAA inaddition to the sealing provided by balloon 30.

For some applications, proximal LAA-orifice cover 70 is bioresorbableand/or drug-eluting.

Reference is now made to FIG. 6, which is a schematic illustration of anocclusion device 110 for occluding an LAA, in accordance with anapplication of the present invention. Occlusion device 110 is for usewith a delivery system 120. Other than as described hereinbelow,occlusion device 110 is similar to occlusion device 10, describedhereinabove with reference to FIGS. 1-5, and may implement any of thefeatures thereof, mutatis mutandis. Similarly, other than as describedhereinbelow, delivery system 120 is similar to delivery system 20,described hereinabove with reference to FIGS. 1-5, and may implement anyof the features thereof, mutatis mutandis. Like reference numerals referto like parts.

Reference is also made to FIGS. 7A-C, which are schematiccross-sectional illustrations of occlusion device 110 and a distalportion of delivery system 120, in accordance with an application of thepresent invention. FIGS. 7A-B show occlusion device 110 connected todelivery system 120, with valve 142 of occlusion device 110 in an openstate, as described hereinbelow. FIG. 7A shows occlusion device 110 withballoon 130 thereof in an elongated state, and FIGS. 7B-C show occlusiondevice 110 with balloon 130 in a shortened state. FIG. 7C showsocclusion device 110 connected to delivery system 120, with valve 142 ina closed state.

For some applications, occlusion device 110 comprises:

-   -   a compliant balloon 130 defining a fluid-tight balloon chamber        132; balloon 130 may have any of the properties of balloon 30,        described hereinabove with reference to FIGS. 1-5;    -   an actuating shaft 134, which is (a) disposed at least partially        within balloon chamber 132, (b) connected to a distal end        portion 136 of balloon 130, and (c) longitudinally moveable with        respect to a proximal end portion 138 of balloon 130 so as to        set a distance between distal and proximal end portions 136 and        138 of balloon 130; and    -   a valve 142, comprising an elastomer sleeve 143 that surrounds a        portion of actuating shaft 134.

Occlusion device 110 is shaped so as to define a fluid flow path 144having one or more fluid-flow-path openings 145 to balloon chamber 132.Typically, occlusion device 110 is configured such that fluid flow path144 is coupled in fluid communication with delivery system 120 whenocclusion device 110 is releasably connected to delivery system 120.

For example, elastomer sleeve 143 may comprise silicone.

Elastomer sleeve 143 is configured to have a resting state in which thesleeve covers and seals the one or more fluid-flow-path openings 145,such that valve 142 is in a closed state, as shown in FIG. 7C.

Delivery system 120 is configured to be releasably connected toocclusion device 110. Delivery system 120 comprises a valve-opening prop147, which is configured:

-   -   when in a propping position, such as shown in FIGS. 6 and 7A-B,        to prop open and deform elastomer sleeve 143 such that elastomer        sleeve 143 does not seal the one or more fluid-flow-path        openings 145 and valve 142 is in an open state, and    -   when in a non-propping position, such as shown in FIG. 7C, not        to prop open elastomer sleeve 143, such that elastomer sleeve        assumes the resting state and valve 142 is in the closed state.

This configuration enables separate control of shortening of balloon 130and closing of valve 142. Alternatively, valve-opening prop 147 (e.g.,tubular portion 151 thereof, described below) is fixed to pull shaft 46.

For some applications, valve-opening prop 147 comprises one or more tabs149 that extend radially outward from an axis of elastomer sleeve 143,so as to prop open elastomer sleeve 143.

For some applications, valve-opening prop 147 is configured such thataxial sliding thereof with respect to elastomer sleeve 143 (e.g., in aproximal direction) transitions valve-opening prop 147 from the proppingposition to the non-propping position, as shown in the transitionbetween FIG. 7B and FIG. 7C.

For some applications, occlusion device 110 further comprises a proximaltube 152, which is axially fixed with respect to proximal end portion138 of balloon 130. For some applications, actuating shaft 134 isslidably disposed partially within proximal tube 152.

For some applications, a seal, such as an O-ring (as shown), isprovided, and friction between the seal and the inner surface of aproximal tube 152 increases structural stability. Alternatively oradditionally, the O-ring, upon completion of the shortening of theballoon, is disposed proximal to the one or more fluid-flow-pathopenings 145 and blocks additional fluid from passing through the one ormore fluid-flow-path openings 145 and elastomer sleeve 143.

For some applications, valve-opening prop 147 comprises a tubularportion 151, which is disposed at least partially within proximal tube152. For some of these applications, valve-opening prop 147 comprisesthe one or more tabs 149, which extend (a) axially away from tubularportion 151 (e.g., in a distal direction) and (b) radially outward fromproximal tube 152, so as to prop open elastomer sleeve 143. For someapplications, the one or more tabs 149 pass through at least a portionof the one or more fluid-flow-path openings 145 when valve-opening prop147 is in the propping position, such as shown in FIGS. 6 and 7A-B.Alternatively, for some applications, proximal tube 152 is shaped so asto define one or more access openings through a wall of proximal tube152, and the one or more tabs 149 pass through the one or more accessopenings at least when valve-opening prop 147 is in the proppingposition (configuration not shown).

For some applications, occlusion device 110 further comprises proximalLAA-orifice cover 70, which is fixed to proximal tube 152 radiallysurrounding proximal tube 152. Proximal LAA-orifice cover 70 mayimplement any of the techniques described hereinabove and/orhereinbelow. For some of these applications, occlusion device 110further comprises an orifice-support stent 290, described hereinbelowwith reference to FIGS. 8 and 9A-B.

For some applications, occlusion device 110 further comprises a lockingmechanism, which is configured to assume locked and unlocked states, andwhich is configured, when in the locked state, to maintain, betweendistal end portion 136 of balloon 130 and proximal end portion 138 ofballoon 130, the distance set using actuating shaft 134. The lockingmechanism may implement any of the locking mechanisms described herein,mutatis mutandis.

For some applications, actuating shaft 134 is shaped so as to define, atleast in part, a distal tip 150 disposed at distal end portion 136 ofballoon 130.

For some applications, occlusion device 110 further comprises connectingstruts 180 fixed to distal end portion 136 of balloon 130 and toproximal end portion 138 of balloon 130. Typically, occlusion device 110is configured such that inflation of balloon chamber 132 plasticallydeforms connecting struts 180. For some applications, occlusion device110 is configured such that shortening of balloon 130 plasticallydeforms connecting struts 180.

For some applications, delivery system 120 further comprising implantcatheter 88, such as described hereinabove with reference to FIGS. 1-5.

Reference is now made to FIG. 7D, which is a schematic illustration ofan occlusion device 410 for occluding an LAA, in accordance with anapplication of the present invention. For clarity of illustration, aballoon is not shown connected to struts 180 in FIG. 7D, even though itis an actual element of the occlusion device. Occlusion device 410 isfor use with a delivery system. Other than as described hereinbelow,occlusion device 410 is similar to occlusion device 110, describedhereinabove with reference to FIGS. 6 and 7A-C, and may implement any ofthe features thereof, mutatis mutandis. Like reference numerals refer tolike parts. Similarly, other than as described hereinbelow, the deliverysystem is similar to delivery system 20, described hereinabove withreference to FIGS. 1-5, and may implement any of the features thereof,mutatis mutandis.

Occlusion device 410 comprises a valve 442, comprising elastomer sleeve143 that surrounds a portion of actuating shaft 134. Elastomer sleeve143 is configured to have a resting state in which the sleeve covers andseals the one or more fluid-flow-path openings 145, such that the valveis in a closed state (not shown in FIG. 7D, but similar to the stateshown in FIG. 7C for occlusion device 110).

Unlike delivery system 120 of occlusion device 110, the delivery systemof the present configuration does not comprise valve-opening prop 147.Instead, the delivery system comprises one or more guidewires 447,which:

-   -   when in a propping position, such as shown in FIG. 7D, prop open        and deform elastomer sleeve 143 such that elastomer sleeve 143        does not seal the one or more fluid-flow-path openings 145 and        valve 442 is in an open state, and    -   when in a non-propping position (not shown in FIG. 7D, but        similar to the state shown in FIG. 7C for occlusion device 110),        do not prop open elastomer sleeve 143, such that elastomer        sleeve assumes the resting state and valve 442 is in the closed        state.

For some applications, the one or more guidewires 447 pass through atleast a portion of the one or more fluid-flow-path openings 145 when theone or more guidewires are in the propping position.

Reference is now made to FIG. 8, which is a schematic illustration of anocclusion device 210 for occluding an LAA, in accordance with anapplication of the present invention. Occlusion device 210 is for usewith a delivery system 220. Occlusion device 210 may be implemented incombination with any of the other occlusion devices described herein,mutatis mutandis, including, but not limited to, any of the valvesand/or locking mechanisms described herein, mutatis mutandis. Similarly,other than as described hereinbelow, delivery system 220 is similar tothe other delivery systems described herein, and may implement any ofthe features thereof, mutatis mutandis. Like reference numerals refer tolike parts.

Reference is also made to FIGS. 9A-B, which are schematiccross-sectional illustrations of occlusion device 210 and a distalportion of delivery system 220, in accordance with an application of thepresent invention. FIG. 9A-B show occlusion device 210 connected todelivery system 220. FIG. 9A shows occlusion device 210 with balloon 230thereof in an elongated state, and FIG. 9B shows occlusion device 210with balloon 230 in a shortened state.

Occlusion device 210 comprises:

-   -   a compliant balloon 230 defining a fluid-tight balloon chamber        232; balloon 230 may have any of the properties of balloon 30,        described hereinabove with reference to FIGS. 1-5;    -   an actuating shaft 234, which is (a) disposed at least partially        within balloon chamber 232, (b) connected to a distal end        portion 236 of balloon 230, and (c) longitudinally moveable with        respect to a proximal end portion 238 of balloon 230 so as to        set a distance between distal and proximal end portions 236 and        238 of balloon 230; and    -   a valve 242, which, as mentioned above, may implement any of the        features of the valves described herein.

Occlusion device 210 further comprises proximal LAA-orifice cover 70,which (a) is configured to assume a radially-compressed state and aradially-expanded state, (b) comprises frame 72 and covering 74 fixed toframe 72, and (c) when in the radially-expanded state, is generallyorthogonal to actuating shaft 234 and has a greatest dimension, measuredperpendicular to actuating shaft 234, of at least 10 mm (e.g., at least20 mm), no more than 50 mm (e.g., no more than 30 mm), and/or between 10and 50 mm (e.g., between 20 and 30 mm).

Occlusion device 210 still further comprises an orifice-support stent290, which is configured to enhance support at the orifice of the LAA.Orifice-support stent 290 is configured to be positioned at leastpartially within the LAA, such as entirely within the LAA.Orifice-support stent 290 is:

-   -   fixed to and extends distally from proximal LAA-orifice cover        70,    -   configured to assume a radially-compressed state (not shown) and        a radially-expanded state (as shown in FIGS. 8 and 9A-B), and    -   generally cylindrical when in the radially-expanded state.

As used in the present application, including in the claims and theInventive Concepts, the phrase “generally cylindrical” is not limited togenerally circularly cylindrical, and also includes within its scopeother generally cylindrical shapes, such as generally ellipticallycylindrical.

For some applications, orifice-support stent 290, when in theradially-expanded state, has (i) a greatest dimension, measuredperpendicular to actuating shaft 234, of at least 8 mm, no more than 50mm, and/or between 8 and 50 mm, and/or (ii) an axial length of at least4 mm (e.g. at least 5 mm), no more than 30 mm, and/or between 4 and 30mm.

For some applications, orifice-support stent 290 is not fixed to balloon230, such that a shape of balloon 230 can change independently of ashape of orifice-support stent 290. Alternatively or additionally, lackof direct physical contact between orifice-support stent 290 andconnecting struts 280 of occlusion device 210 prevents an anodicreaction between the typically super-elastic (e.g., Nitinol) material ofstruts 280 and the typically plastically deformable (e.g., stainlesssteel) material of orifice-support stent 290. Such a reaction might haveoccurred if the two elements were instead welded or otherwise bondedtogether in contact with each other. (Connection of the elements via anindependent and passive element, such as an internal tube or shaft, alsodoes not cause such a reaction.)

For some applications, orifice-support stent 290 comprises asuper-elastic or plastically-deformable metal.

Typically, occlusion device 210 is configured such that inflation ofballoon chamber 232 transitions orifice-support stent 290 from itsradially-compressed state to its radially-expanded state. For someapplications, because orifice-support stent 290 comprises asuper-elastic metal, such as Nitinol, the stent, when crimped, will havea minimum diameter given by the thickness of its wall struts. Whenreleased, the stent tends to transition to its released diameter, whichis higher than the crimped diameter. In configurations in which balloon230 is inflated within the stent, the stent will over-stretch, and itsdiameter will be greater than its released diameter, to an extent thatdepends upon the design and ability of over-dilatation of the stentstruts.

For some applications, occlusion device 210 further comprises a proximaltube 252, which is axially fixed with respect to proximal end portion238 of balloon 230. For these applications, proximal LAA-orifice cover70 is fixed to proximal tube 252 radially surrounding proximal tube 252,and is indirectly connected to balloon 230 via proximal tube 252 and isnot directly connected to balloon 230.

Reference is now made to FIG. 10, which is a schematic illustration ofan occlusion device 310 for occluding an LAA, in accordance with anapplication of the present invention. Occlusion device 310 is for usewith a delivery system 320. Other than as described hereinbelow,occlusion device 310 is similar to occlusion device 10, describedhereinabove with reference to FIGS. 1-5, and may implement any of thefeatures thereof, mutatis mutandis. Similarly, other than as describedhereinbelow, delivery system 320 is similar to delivery system 20,described hereinabove with reference to FIGS. 1-5, and may implement anyof the features thereof, mutatis mutandis. Like reference numerals referto like parts.

Reference is also made to FIG. 11, which is a schematic cross-sectionalillustration of occlusion device 310 and a distal portion of deliverysystem 320, in accordance with an application of the present invention.Both FIG. 10 and FIG. 11 show occlusion device 310 connected to deliverysystem 320. FIG. 10 shows occlusion device 310 with balloon 330 thereofin an elongated state, and FIG. 11 shows occlusion device 310 withballoon 330 in a shortened state, as described hereinbelow.

Occlusion device 310 comprises:

-   -   a compliant balloon 330 defining a fluid-tight balloon chamber        332; balloon 330 may have any of the properties of balloon 30,        described hereinabove with reference to FIGS. 1-5;    -   a proximal tube 352, which is axially fixed with respect to a        proximal end portion 338 of balloon 330;    -   a spring 353; and    -   a valve 342, which may implement any of the features of the        valves described herein.

Spring 353 is (a) disposed at least partially within balloon chamber232, (b) connected (directly or indirectly, such as via a tube) to adistal end portion 336 of balloon 330 and proximal tube 352, and (c) hasa relaxed length, as shown in FIG. 11. When spring 353 has the relaxedlength, distal end portion 336 of balloon 330 is at a relaxed distancefrom proximal end portion 338 of balloon 330, as shown in FIG. 11.

Delivery system 320 is configured to be releasably connected toocclusion device 310. Delivery system 320 comprises a stylet 355, whichis removably disposed through proximal tube 352 and within spring 353.Occlusion device 310 is configured such that a degree of distaladvancement of stylet 355 within spring 353 sets a tensed length ofspring 353, which in turn sets a tensed distance between distal andproximal end portions 336 and 338 of balloon 330, the tensed distancegreater than the relaxed distance. One possible tensed distance is shownin FIG. 10.

Typically, during deployment of occlusion device 310 in the LAA,occlusion device 310 is advanced into the LAA with spring 353 in theelongated tensed state. Balloon chamber 332 is typically inflated whilespring 353 is in the elongated tensed state, such as shown in FIG. 10,and valve 342 is transitioned to the closed state, such as usingtechniques described herein. Thereafter, stylet 355 is partiallyproximally withdrawn, allowing spring 353 to shorten to its restingstate, as shown in FIG. 11.

For some applications, a distal end portion of stylet 355 is releasablyconnected to an occlusion-device connector 357 of occlusion device 310,which is connected to distal end portion 336 of balloon 330. (Eventhough stylet 355 would generally remain in place even if not connectedto occlusion device 310, if not thus connected stylet 355 might becomedisengaged from the center of spring 353 and become entangled withspring 353 during maneuvering of occlusion device 310 and inflation ofballoon 330 during deployment.) For these applications, stylet 355 isdisconnected from occlusion-device connector 357 after spring 353 hasbeen allowed to shorten. For example, the end portion of stylet 355 andocclusion-device connector 357 may define respective threads.

Optionally, stylet 355 is flexible, e.g., highly flexible, toaccommodate variations in LAA anatomy, including curvature of the LAA.

Reference is now made to FIGS. 12A-B, 13A-B, and 14A-B, which areschematic illustrations of an occlusion device 510 for occluding an LAA,in accordance with an application of the present invention. Occlusiondevice 510 is for use with a delivery system, such as delivery system20, described hereinabove with reference to FIGS. 1-4C; delivery system120, described hereinabove with reference to FIGS. 6-7C; delivery system220, described hereinabove with reference to FIGS. 8-9B; or deliverysystem 320, described hereinabove with reference to FIGS. 10-11, mutatismutandis. Other than as described hereinbelow, occlusion device 510 issimilar to occlusion device 10, described hereinabove with reference toFIGS. 1-5, and may implement any of the features thereof, mutatismutandis. Like reference numerals refer to like parts. Alternatively oradditionally, occlusion device 510 may optionally implement any of thefeatures of occlusion device 110, described hereinabove with referenceto FIGS. 6 and 7A-C; occlusion device 210, described hereinabove withreference to FIGS. 8 and 9A-B; occlusion device 310, describedhereinabove with reference to FIGS. 10 and 11; and/or occlusion device410, described hereinabove with reference to FIG. 7D, mutatis mutandis.By way of example and not limitation, occlusion device 510 mayoptionally comprise proximal LAA-orifice cover 70, such as shown in thefigures. Similarly, these other occlusion devices described herein mayoptionally implement any of the features of occlusion device 510,mutatis mutandis.

FIGS. 12A-B show occlusion device 510 after sheath 82, shown in FIG. 3A,has been proximally withdraw, thereby releasing occlusion device 510,and allowing proximal LAA-orifice cover 70 to transition to itsradially-expanded state. This is similar to the state of deployment ofocclusion device 10 shown in FIG. 3B. Balloon 30 remains in anon-inflated, elongate configuration at this stage of deployment.

FIGS. 13A-B show occlusion device 510 upon partial inflation of balloonchamber 32.

FIGS. 14A-B show occlusion device 510 upon final inflation of balloonchamber 32. Balloon chamber 32 can be inflated at different finalinflation levels, depending on the extent of radial expansion necessaryfor the particular anatomy of the LAA. Typically, occlusion device 510is configured to be radially expandable to a diameter of between 15 and40 mm, e.g., between 20 and 35 mm, such as between 15 and 35 mm.

Occlusion device 510 comprises connecting struts 580 fixed to distal endportion 36 of balloon 30 and to proximal end portion 38 of balloon 30.Struts 580 may implement any of the features of struts 80, describedhereinabove, mutatis mutandis. First lateral portions 581A of struts 580are arranged along a lateral surface of balloon 30. Second distal-endportions 581B of struts 580 are arranged on a distal surface of balloon30. Third proximal-end portions 581C of struts 580 are arranged on aproximal surface of balloon 30. Typically, second distal-end portions581B and third proximal-end portions 581C are generally straight.Typically, first lateral portions 581A are oriented parallel to acentral longitudinal axis of occlusion device 510.

For some applications, distal interface portions 583A of struts 580 joinfirst lateral portions 581A and second distal-end portions 581B,respectively, and/or proximal interface portions 583B join first lateralportions 581A and third proximal-end portions 581C, respectively.Occlusion device 510 is configured such that upon inflation of balloonchamber 32, distal interface portions 583A and proximal interfaceportions 583B are curved, such as shown in FIGS. 13A-B and 14A-B. (FIGS.12A-B shown balloon chamber 32 uninflated, FIGS. 13A-B show balloonchamber 32 partially inflated, and FIGS. 14A-B show balloon chamber 32finally inflated.) For some of these applications, distal interfaceportions 583A and/or proximal interface portions 583B have a serpentine(e.g., sinusoidal) shape, as shown. This serpentine shape causes distalinterface portions 583A and/or proximal interface portions 583B to bemore compliant than first lateral portions 581A, second distal-endportions 581B, and/or third proximal-end portions 581C. As a result,occlusion device 510, upon inflation and shortening of balloon 30,assumes a more cylindrical shape that it otherwise would. Optionally,first lateral portions 581A of struts 580 are generally straight, whichalso contributes to the cylindrical shape of occlusion device 510.

For some applications, distal end portions 585A of struts 580 joinsecond distal-end portions 581B of struts 580 to distal end portion 36of balloon 30, respectively, and/or proximal end portions 585B of struts580 join third proximal-end portions 581C of struts 580 to proximal endportion 38 of balloon 30, respectively. Occlusion device 510 isconfigured such that upon inflation of balloon chamber 32, distal endportions 585A and proximal end portions 585B are curved. (FIGS. 12A-Bshown balloon chamber 32 uninflated, FIGS. 13A-B show balloon chamber 32partially inflated, and FIGS. 14A-B show balloon chamber 32 finallyinflated.) For some of these applications, distal end portions 585Aand/or proximal end portions 585B have a serpentine (e.g., sinusoidal)shape, as shown. This serpentine shape allows distal end portions 585Aand/or proximal end portions 585B to elongate, thereby allowingocclusion device 510 to radially expand, such as to a diameter, forexample, of between 15 and 40 mm, e.g., between 20 and 35 mm, such asbetween 15 and 35 mm. This serpentine shape also allows distal endportions 585A and/or proximal end portions 585B to selectively elongate,thereby accommodating expansion of balloon 30 to different extents indifferent radial directions.

For some applications, struts 580 are shaped so as to define a pluralityof spikes 589 that extend from outer ends 599 (labeled in FIGS. 12A and14A) of second distal-end portions 581B, respectively, and/or thirdproximal-end portions 581C, respectively. Spikes 589 are initiallygenerally axially oriented, when balloon 30 is in a non-inflated,elongate configuration, as shown in FIGS. 12A-B. Spikes 589 areconfigured to extend more radially upon inflation of balloon chamber 32to serve as tissue-engaging barbs, as shown in FIGS. 14A-B. Therespective axes of spikes 589 may be parallel with or slightly angledwith respect to axes of second distal-end portions 581B and thirdproximal-end portions 581C.

For some applications, distal interface portions 583A are shaped so asto define respective pairs of parallel serpentine (e.g., sinusoidal)struts 591A and 591B that define respective narrow elongate gaps 593therebetween. When spikes 589 are initially generally axially oriented,as shown in FIGS. 12A-B, the spikes are disposed in respective gaps 593.Respective tips 595 of spikes 589 are disposed near respective endsurfaces 597 of gaps 593 at respective junctions between the parallelserpentine struts 591A and 591B, such that the respective tips 595 ofspikes 589 are protected by respective end surfaces 597 until the spikesare radially deployed. Alternatively or additionally, proximal interfaceportions 583B and their corresponding spikes 589 may implement thisfeature.

For some applications, connecting struts 580 further include closedstent cells 587 that connect adjacent pairs of first lateral portions581A. Optionally, two or more closed stent cells 587 arranged in seriesconnect the adjacent pairs of first lateral portions 581A (in thefigures, exactly two closed stent cells 587 arranged in series are shownconnecting the adjacent pairs of first lateral portions 581A);typically, no more than four closed stent cells 587 arranged in series,such as exactly two or three closed stent cells 587 arranged in series.These connections by closed stent cells 587 may help laterally stabilizefirst lateral portions 581A upon inflation of balloon chamber 32, andmay help constrain the shape of balloon 30 upon inflation of balloonchamber 32, by helping limit radial expansion of the balloon out of thestent struts. These connections by closed stent cells 587 mayalternatively or additionally stabilize the implantation of occlusiondevice 510 by friction, by providing a sufficiently large contractsurface with the walls of the LAA. Optionally, a single series of two ormore closed stent cells 587 connect adjacent pairs of first lateralportions 581A, as shown; alternatively, two or more series (e.g.,exactly two series) of two or more closed stent cells 587 connectadjacent pairs of first lateral portions 581A (configuration not shown).

Typically, an average width of the struts of first lateral portions 581Aequals at least 200% of an average width of the struts of closed stentcells 587, such as at least 250%, 300%, or 400%. As mentioned above,typically first lateral portions 581A are oriented parallel to a centrallongitudinal axis of occlusion device 510. The struts of closed stentcells 587 may have these thinner widths in order to allow expansion ofthe closed stent cells with the expansion of the balloon.

For some applications, closed stent cells 587 are shaped as respectiverhombuses. Rhombuses can be radially compressed for delivery such thatthey predictably expand symmetrically, unlike many other stent shapesthat tend to expand asymmetrically, such as S-shapes and serpentineshapes. Rhombuses also generally return to their original shape whenplastically expanded for implantation after being plastically radiallycompressed for delivery. For some applications, the rhombuses may beshaped as squares and/or diamonds at certain levels of radialcompression and expansion.

In an embodiment, the techniques and apparatus described herein arecombined with techniques and apparatus described in one or more of thefollowing patent applications, which are assigned to the assignee of thepresent application and are incorporated herein by reference:

-   -   European Patent Application Publication EP 3 459 469 A1 to        Maisano et al.;    -   PCT Publication WO 2019/057950 to Maisano et al.;    -   PCT Publication WO 2020/060587 to Maisano et al.; and/or    -   U.S. Provisional Application 62/906,393, filed Sep. 26, 2019.

It will be appreciated by persons skilled in the art that the presentinvention is not limited to what has been particularly shown anddescribed hereinabove. Rather, the scope of the present inventionincludes both combinations and subcombinations of the various featuresdescribed hereinabove, as well as variations and modifications thereofthat are not in the prior art, which would occur to persons skilled inthe art upon reading the foregoing description.

1. An occlusion device for occluding a left atrial appendage (LAA), theocclusion device for use with a delivery system, the occlusion devicecomprising: a compliant balloon defining a fluid-tight balloon chamber;an actuating shaft, which is (a) disposed at least partially within theballoon chamber, (b) connected to a distal end portion of the balloon,and (c) longitudinally moveable with respect to a proximal end portionof the balloon so as to set a distance between the distal and theproximal end portions of the balloon; a proximal LAA-orifice cover,which (a) is configured to assume a radially-compressed state and aradially-expanded state, (b) comprises a frame and a covering fixed tothe frame, and (c) when in the radially-expanded state, is generallyorthogonal to the actuating shaft and has a greatest dimension, measuredperpendicular to the actuating shaft, of between 10 and 50 mm; and anorifice-support stent, which (a) is fixed to and extends distally fromthe proximal LAA-orifice cover, (b) is configured to assume aradially-compressed state and a radially-expanded state, and (c) isgenerally cylindrical when in the radially-expanded state.
 2. Theocclusion device according to claim 1, wherein the orifice-supportstent, when in the radially-expanded state, has (i) a greatestdimension, measured perpendicular to the actuating shaft, of between 8and 50 mm, and (ii) an axial length of between 4 and 30 mm.
 3. Theocclusion device according to claim 1, wherein the occlusion devicefurther comprises a distal tip disposed at the distal end portion of theballoon, wherein the actuating shaft is connected to the distal tip. 4.The occlusion device according to claim 1, wherein the actuating shaftis shaped so as to define, at least in part, a distal tip disposed atthe distal end portion of the balloon.
 5. The occlusion device accordingto claim 1, wherein the occlusion device further comprises a proximalbase disposed at the proximal end portion of the balloon, wherein theactuating shaft is moveable with respect to the proximal base.
 6. Theocclusion device according to claim 1, for use with a guidewire, whereinthe actuating shaft is shaped so as to define a guidewire lumen forslidingly receiving therein the guidewire.
 7. The occlusion deviceaccording to claim 1, wherein the compliant balloon comprises acompliant material selected from the group consisting of:polycaprolactone (PCL), polyglycolic acid (PGA), polylactic acid (PLA),and polydioxanone (PDO or PDS), silicone, polyurethane,polytetrafluoroethylene (PTFE), polymethylmethacrylate, polyether etherketone (PEEK), polyvinyl chloride, polyethylene terephthalate, nylon,polyamide, polyamide, and polyether block amide (PEBA).
 8. The occlusiondevice according to any one of claims 1-7, wherein the orifice-supportstent is not fixed to the balloon, such that a shape of the balloon canchange independently of a shape of the orifice-support stent.
 9. Theocclusion device according to any one of claims 1-7, wherein theocclusion device is configured such that inflation of the balloonchamber transitions the orifice-support stent from itsradially-compressed state to its radially-expanded state.
 10. Theocclusion device according to any one of claims 1-7, wherein theocclusion device further comprises a proximal tube, which is axiallyfixed with respect to the proximal end portion of the balloon, andwherein the proximal LAA-orifice cover is fixed to the proximal tuberadially surrounding the proximal tube, and is indirectly connected tothe balloon via the proximal tube and is not directly connected to theballoon.
 11. The occlusion device according to claim 10, wherein theactuating shaft is slidably disposed partially within the proximal tube.12. The occlusion device according to any one of claims 1-7, wherein theocclusion device further comprises connecting struts fixed to the distalend portion of the balloon and to the proximal end portion of theballoon.
 13. The occlusion device according to claim 12, wherein theocclusion device is configured such that inflation of the balloonchamber plastically deforms the connecting struts.
 14. The occlusiondevice according to claim 12, wherein the occlusion device is configuredsuch that shortening of the balloon plastically deforms the connectingstruts.
 15. The occlusion device according to any one of claims 1-7,wherein the balloon has an average wall thickness of between 100 and5000 microns.
 16. The occlusion device according to any one of claims1-7, wherein the balloon has, at a thinnest portion of a wall of theballoon, a thinnest wall thickness of between 20 and 500 microns.
 17. Anocclusion system comprising the occlusion device according to any one ofclaims 1-7, the occlusion system further comprising an implant catheter,in which the occlusion device is releasably disposed in aradially-compressed state, in which a greatest distance between theproximal end portion of the balloon and the distal end portion of theballoon is between 8 and 80 mm.
 18. The occlusion device according toany one of claims 1-7, further comprising a valve.
 19. The occlusiondevice according to claim 18, wherein the occlusion device is shaped soas to define a fluid flow path, and wherein the valve is configured toselectively allow or block fluid flow between the fluid flow path andthe balloon chamber when the valve is in open and closed states,respectively.
 20. The occlusion device according to claim 19, whereinthe occlusion device is shaped so as to define the fluid flow path alonga portion of the actuating shaft, wherein the occlusion device furthercomprises a locking mechanism, which is configured to assume locked andunlocked states, and which is configured, when in the locked state, tomaintain, between the distal end portion of the balloon and the proximalend portion of the balloon, the distance set using the actuating shaft,and wherein the occlusion device is configured such that reduction ofthe distance, by proximal longitudinal movement of the actuating shaft:(a) to a first predetermined distance between the distal and theproximal end portions of the balloon automatically transitions the valvefrom the open state to the closed state, and (b) to a secondpredetermined distance between the distal and the proximal end portionsof the balloon automatically transitions the locking mechanism from theunlocked state to the locked state.
 21. The occlusion device accordingto claim 20, wherein the occlusion device is configured to be releasablyconnected to the delivery system, and wherein the occlusion device isconfigured such that the fluid flow path is coupled in fluidcommunication with the delivery system when the occlusion device isreleasably connected to the delivery system.
 22. The occlusion deviceaccording to claim 1, wherein the occlusion device further comprises aproximal connector that is configured to releasably connect theocclusion device to a correspondingly configured distal connector of thedelivery system.
 23. The occlusion device according to claim 22, whereinthe proximal connector is shaped so as to define a thread.
 24. Anocclusion system comprising the occlusion device according to any one ofclaims 22-23, the occlusion system for use with a guidewire and furthercomprising the delivery system cooperating therewith, the deliverysystem comprising an implant catheter connected to an operating handle,the implant catheter comprising a longitudinal passageway for theguidewire, a distal connector for releasably connecting the implantcatheter to the correspondingly configured proximal connector of theocclusion device, and an inflation tube channel releasably connectableto the fluid flow path of the occlusion device.
 25. An occlusion devicefor occluding a left atrial appendage (LAA), the occlusion device foruse with a delivery system, the occlusion device comprising: a compliantballoon defining a fluid-tight balloon chamber; an actuating shaft,which is (a) disposed at least partially within the balloon chamber, (b)connected to a distal end portion of the balloon, and (c) longitudinallymoveable with respect to a proximal end portion of the balloon so as toset a distance between the distal and the proximal end portions of theballoon; a locking mechanism, which is configured to assume locked andunlocked states, and which is configured, when in the locked state, tomaintain, between the distal end portion of the balloon and the proximalend portion of the balloon, the distance set using the actuating shaft;and a valve, wherein the occlusion device is shaped so as to define afluid flow path along a portion of the actuating shaft, wherein thevalve is configured to selectively allow or block fluid flow between thefluid flow path and the balloon chamber when the valve is in open andclosed states, respectively, and wherein the occlusion device isconfigured such that reduction of the distance, by proximal longitudinalmovement of the actuating shaft: (a) to a first predetermined distancebetween the distal and the proximal end portions of the balloonautomatically transitions the valve from the open state to the closedstate, and (b) to a second predetermined distance between the distal andthe proximal end portions of the balloon automatically transitions thelocking mechanism from the unlocked state to the locked state.
 26. Theocclusion device according to claim 25, wherein the first predetermineddistance does not equal the second predetermined distance.
 27. Theocclusion device according to claim 26, wherein the first predetermineddistance is less than the second predetermined distance.
 28. Theocclusion device according to claim 25, wherein the first predetermineddistance equals the second predetermined distance.
 29. The occlusiondevice according to claim 25, wherein the occlusion device is configuredto be releasably connected to the delivery system, and wherein theocclusion device is configured such that the fluid flow path is coupledin fluid communication with the delivery system when the occlusiondevice is releasably connected to the delivery system.
 30. The occlusiondevice according to claim 25, wherein the occlusion device furthercomprises a distal tip disposed at the distal end portion of theballoon, wherein the actuating shaft is connected to the distal tip. 31.The occlusion device according to claim 25, wherein the actuating shaftis shaped so as to define, at least in part, a distal tip disposed atthe distal end portion of the balloon.
 32. The occlusion deviceaccording to claim 25, wherein the occlusion device further comprises aproximal base disposed at the proximal end portion of the balloon,wherein the actuating shaft is moveable with respect to the proximalbase.
 33. The occlusion device according to claim 25, for use with aguidewire, wherein the actuating shaft is shaped so as to define aguidewire lumen for slidingly receiving therein the guidewire.
 34. Theocclusion device according to claim 25, wherein the compliant ballooncomprises a compliant material selected from the group consisting of:polycaprolactone (PCL), polyglycolic acid (PGA), polylactic acid (PLA),and polydioxanone (PDO or PDS), silicone, polyurethane,polytetrafluoroethylene (PTFE), polymethylmethacrylate, polyether etherketone (PEEK), polyvinyl chloride, polyethylene terephthalate, nylon,polyamide, polyamide, and polyether block amide (PEBA).
 35. Theocclusion device according to any one of claims 25-34, wherein theocclusion device is shaped so as to define the fluid flow path alongsidethe portion of the actuating shaft.
 36. The occlusion device accordingto any one of claims 25-34, wherein the valve is disposed along theactuating shaft.
 37. The occlusion device according to any one of claims25-34, wherein the occlusion device further comprises a proximal tube,which is axially fixed with respect to the proximal end portion of theballoon, wherein the actuating shaft is slidably disposed partiallywithin the proximal tube.
 38. The occlusion device according to claim37, wherein the occlusion device is shaped so as to define the fluidflow path along the portion of the actuating shaft radially between anexternal surface of the actuating shaft and an internal surface of theproximal tube.
 39. The occlusion device according to claim 38, whereinthe valve is disposed along the actuating shaft.
 40. The occlusiondevice according to claim 39, wherein the valve comprises a seal aroundat least a portion of the external surface of the actuating shaft, andwherein the valve is configured to assume the open state when the sealis disposed at one or more first axial positions with respect to theproximal tube, and the closed state when the seal is disposed at one ormore second axial positions with respect to the proximal tube, the oneor more second axial positions proximal to the one or more first axialpositions.
 41. The occlusion device according to claim 40, wherein theseal, the actuating shaft, and the proximal tube are arranged such thatthe seal blocks fluid flow out of a distal end of the proximal tube atleast when the seal is disposed at the one or more first axial positionswith respect to the proximal tube.
 42. The occlusion device according toclaim 38, wherein a wall of the proximal tube is shaped so as to defineone or more tabs through the wall, wherein the one or more tabs arebiased to flex radially inward, and wherein, when the valve is in theopen state, the fluid flow path passes through the wall betweenrespective proximal ends of the one or more tabs and a non-tabbedportion of the wall axially adjacent the one or more tabs.
 43. Theocclusion device according to claim 42, wherein the non-tabbed portionof the wall is disposed proximal to the one or more tabs.
 44. Theocclusion device according to claim 42, wherein the external surface ofthe actuating shaft is shaped so as to define one or more protrusionsaround at least a portion of the actuating shaft, and wherein theproximal ends of the one or more tabs are shaped so as to prevent distalmovement of the one or more protrusions when the one or more protrusionsare disposed proximal to the proximal ends of the one or more tabs,thereby causing the locking mechanism to assume the locked state. 45.The occlusion device according to claim 37, wherein the occlusion devicefurther comprises a proximal LAA-orifice cover, which (a) is fixed tothe proximal tube radially surrounding the proximal tube, (b) isconfigured to assume a radially-compressed state and a radially-expandedstate, (c) comprises a frame and a covering fixed to the frame, (d) whenin the radially-expanded state, is generally orthogonal to the proximaltube and has a greatest dimension, measured perpendicular to theproximal tube, of between 10 and 50 mm, and (e) is indirectly connectedto the balloon via the proximal tube and is not directly connected tothe balloon.
 46. The occlusion device according to claim 45, wherein theocclusion device further comprises an orifice-support stent, which (a)is fixed to and extends distally from the proximal LAA-orifice cover,(b) is configured to assume a radially-compressed state and aradially-expanded state, and (c) is generally cylindrical when in theradially-expanded state.
 47. The occlusion device according to claim 46,wherein the orifice-support stent, when in the radially-expanded state,has (i) a greatest dimension, measured perpendicular to the actuatingshaft, of between 8 and 50 mm, and (ii) an axial length of between 4 and30 mm.
 48. The occlusion device according to any one of claims 25-34,wherein the occlusion device further comprises connecting struts fixedto the distal end portion of the balloon and to the proximal end portionof the balloon.
 49. The occlusion device according to claim 48, whereinthe occlusion device is configured such that inflation of the balloonchamber plastically deforms the connecting struts.
 50. The occlusiondevice according to claim 48, wherein the occlusion device is configuredsuch that shortening of the balloon plastically deforms the connectingstruts.
 51. The occlusion device according to any one of claims 25-34,wherein the balloon has an average wall thickness of between 100 and5000 microns.
 52. The occlusion device according to any one of claims25-34, wherein the balloon has, at a thinnest portion of a wall of theballoon, a thinnest wall thickness of between 20 and 500 microns.
 53. Anocclusion system comprising the occlusion device according to any one ofclaims 25-34, the occlusion system further comprising an implantcatheter, in which the occlusion device is releasably disposed in aradially-compressed state, in which a greatest distance between theproximal end portion of the balloon and the distal end portion of theballoon is between 8 and 80 mm.
 54. The occlusion device according toany one of claims 25-34, wherein the occlusion device further comprisesa proximal connector that is configured to releasably connect theocclusion device to a correspondingly configured distal connector of thedelivery system.
 55. The occlusion device according to claim 54, whereinthe proximal connector is shaped so as to define a thread.
 56. Anocclusion system comprising the occlusion device according to any one ofclaims 25-34, the occlusion system for use with a guidewire and furthercomprising the delivery system cooperating therewith, the deliverysystem comprising an implant catheter connected to an operating handle,the implant catheter comprising a longitudinal passageway for theguidewire, a distal connector for releasably connecting the implantcatheter to the correspondingly configured proximal connector of theocclusion device, and an inflation tube channel releasably connectableto the fluid flow path of the occlusion device.
 57. An occlusion devicefor occluding a left atrial appendage (LAA), the occlusion device foruse with a delivery system, the occlusion device comprising: a compliantballoon defining a fluid-tight balloon chamber; an actuating shaft,which is (a) disposed at least partially within the balloon chamber, (b)connected to a distal end portion of the balloon, and (c) longitudinallymoveable with respect to a proximal end portion of the balloon so as toset a distance between the distal and the proximal end portions of theballoon; and connecting struts fixed to the distal end portion of theballoon and to the proximal end portion of the balloon, wherein theconnecting struts include: first lateral portions arranged along alateral surface of the balloon, second distal-end portions arranged on adistal surface of the balloon, third proximal-end portions arranged on aproximal surface of the balloon, and distal end portions that join thesecond distal-end portions of the struts to the distal end portion ofthe balloon, respectively, and have a serpentine shape, wherein theocclusion device is configured such that upon inflation of the balloonchamber, the distal end portions are curved.
 58. The occlusion deviceaccording to claim 57, wherein the connecting struts include proximalend portions that join the third proximal-end portions of the struts tothe proximal end portion of the balloon, respectively, and have aserpentine shape, and wherein the occlusion device is configured suchthat upon inflation of the balloon chamber, the proximal end portionsare curved.
 59. The occlusion device according to claim 57, wherein theconnecting struts include distal interface portions that join the firstlateral portions and the second distal-end portions, respectively, andhave a serpentine shape, and wherein the occlusion device is configuredsuch that upon inflation of the balloon chamber, the distal interfaceportions are curved.
 60. The occlusion device according to claim 57,wherein the connecting struts include proximal interface portions thatjoin the first lateral portions and the third proximal-end portions,respectively, and have a serpentine shape, and wherein the occlusiondevice is configured such that upon inflation of the balloon chamber,the proximal interface portions are curved.
 61. The occlusion deviceaccording to claim 57, wherein the first lateral portions of the strutsare generally straight.
 62. The occlusion device according to claim 57,wherein the second distal-end portions and the third proximal-endportions are generally straight.
 63. The occlusion device according toclaim 57, wherein the first lateral portions of the struts are generallystraight, and the second distal-end portions and the third proximal-endportions are generally straight.
 64. The occlusion device according toclaim 57, wherein the occlusion device is configured such that inflationof the balloon chamber plastically deforms the connecting struts. 65.The occlusion device according to claim 57, wherein the occlusion deviceis configured such that shortening of the balloon plastically deformsthe connecting struts.
 66. The occlusion device according to any one ofclaims 57-65, wherein the distal interface portions are shaped so as todefine respective pairs of parallel serpentine struts that definerespective narrow elongate gaps therebetween, and wherein the struts areshaped so as to define a plurality of spikes, which: extend from outerends of the second distal-end portions, respectively, are disposed inthe respective narrow elongate gaps, generally axially oriented, whenthe balloon is in a non-inflated, elongate configuration, and areconfigured to extend more radially upon inflation of the balloon chamberto serve as tissue-engaging barbs.
 67. The occlusion device according toany one of claims 57-65, wherein the connecting struts further includeclosed stent cells that connect adjacent pairs of the first lateralportions.
 68. The occlusion device according to claim 67, wherein two ormore of the closed stent cells arranged in series connect the adjacentpairs of the first lateral portions.
 69. The occlusion device accordingto claim 67, wherein the closed stent cells are shaped as respectiverhombuses.
 70. The occlusion device according to claim 67, wherein thefirst lateral portions are oriented parallel to a central longitudinalaxis of the occlusion device.
 71. The occlusion device according toclaim 67, wherein an average width of the struts of first lateralportions equals at least 200% of an average width of the struts of theclosed stent cells.
 72. An occlusion device for occluding a left atrialappendage (LAA), the occlusion device for use with a delivery system,the occlusion device comprising: a compliant balloon defining afluid-tight balloon chamber; an actuating shaft, which is (a) disposedat least partially within the balloon chamber, (b) connected to a distalend portion of the balloon, and (c) longitudinally moveable with respectto a proximal end portion of the balloon so as to set a distance betweenthe distal and the proximal end portions of the balloon; and connectingstruts fixed to the distal end portion of the balloon and to theproximal end portion of the balloon, wherein the connecting strutsinclude: first lateral portions arranged along a lateral surface of theballoon, second distal-end portions arranged on a distal surface of theballoon, third proximal-end portions arranged on a proximal surface ofthe balloon, and distal interface portions that join the first lateralportions and the second distal-end portions, respectively, and have aserpentine shape, wherein the occlusion device is configured such thatupon inflation of the balloon chamber, the distal interface portions arecurved.
 73. The occlusion device according to claim 72, wherein theconnecting struts include proximal interface portions that join thefirst lateral portions and the third proximal-end portions,respectively, and have a serpentine shape, and wherein the occlusiondevice is configured such that upon inflation of the balloon chamber,the proximal interface portions are curved.
 74. The occlusion deviceaccording to claim 72, wherein the first lateral portions of the strutsare generally straight.
 75. The occlusion device according to claim 72,wherein the second distal-end portions and the third proximal-endportions are generally straight.
 76. The occlusion device according toclaim 72, wherein the first lateral portions of the struts are generallystraight, and the second distal-end portions and the third proximal-endportions are generally straight.
 77. The occlusion device according toclaim 72, wherein the occlusion device is configured such that inflationof the balloon chamber plastically deforms the connecting struts. 78.The occlusion device according to claim 72, wherein the occlusion deviceis configured such that shortening of the balloon plastically deformsthe connecting struts.
 79. The occlusion device according to claim 72,wherein the connecting struts include distal end portions that join thesecond distal-end portions of the struts to the distal end portion ofthe balloon, respectively, and have a serpentine shape, and wherein theocclusion device is configured such that upon inflation of the balloonchamber, the distal end portions are curved.
 80. The occlusion deviceaccording to claim 72, wherein the connecting struts include proximalend portions that join the third proximal-end portions of the struts tothe proximal end portion of the balloon, respectively, and have aserpentine shape, and wherein the occlusion device is configured suchthat upon inflation of the balloon chamber, the proximal end portionsare curved.
 81. The occlusion device according to any one of claims72-80, wherein the distal interface portions are shaped so as to definerespective pairs of parallel serpentine struts that define respectivenarrow elongate gaps therebetween, and wherein the struts are shaped soas to define a plurality of spikes, which: extend from outer ends of thesecond distal-end portions, respectively, are disposed in the respectivenarrow elongate gaps, generally axially oriented, when the balloon is ina non-inflated, elongate configuration, and are configured to extendmore radially upon inflation of the balloon chamber to serve astissue-engaging barbs.
 82. The occlusion device according to any one ofclaims 72-80, wherein the connecting struts further include closed stentcells that connect adjacent pairs of the first lateral portions.
 83. Theocclusion device according to claim 82, wherein two or more of theclosed stent cells arranged in series connect the adjacent pairs of thefirst lateral portions.
 84. The occlusion device according to claim 82,wherein the closed stent cells are shaped as respective rhombuses. 85.The occlusion device according to claim 82, wherein the first lateralportions are oriented parallel to a central longitudinal axis of theocclusion device.
 86. The occlusion device according to claim 82,wherein an average width of the struts of first lateral portions equalsat least 200% of an average width of the struts of the closed stentcells.
 87. An occlusion device for occluding a left atrial appendage(LAA), the occlusion device for use with a delivery system, theocclusion device comprising: a compliant balloon defining a fluid-tightballoon chamber; an actuating shaft, which is (a) disposed at leastpartially within the balloon chamber, (b) connected to a distal endportion of the balloon, and (c) longitudinally moveable with respect toa proximal end portion of the balloon so as to set a distance betweenthe distal and the proximal end portions of the balloon; and connectingstruts fixed to the distal end portion of the balloon and to theproximal end portion of the balloon, wherein the connecting strutsinclude: first lateral portions arranged along a lateral surface of theballoon, and closed stent cells that connect adjacent pairs of the firstlateral portions.
 88. The occlusion device according to claim 87,wherein two or more of the closed stent cells arranged in series connectthe adjacent pairs of the first lateral portions.
 89. The occlusiondevice according to claim 87, wherein the closed stent cells are shapedas respective rhombuses.
 90. The occlusion device according to claim 87,wherein the first lateral portions are oriented parallel to a centrallongitudinal axis of the occlusion device.
 91. The occlusion deviceaccording to claim 87, wherein an average width of the struts of firstlateral portions equals at least 200% of an average width of the strutsof the closed stent cells.
 92. A method for occluding a left atrialappendage (LAA) of a patient, the method including: using a deliverysystem, positioning: a compliant balloon of an occlusion device in alongitudinally extended form thereof in the LAA, an actuating shaft ofthe occlusion device in the LAA, wherein the actuating shaft is (a)disposed at least partially within the balloon chamber, (b) connected toa distal end portion of the balloon, and (c) longitudinally moveablewith respect to a proximal end portion of the balloon so as to set adistance between the distal and the proximal end portions of theballoon, a proximal LAA-orifice cover in a left atrium outside the LAA,against an atrial wall surrounding an orifice of the LAA, wherein theproximal LAA-orifice cover is (a) configured to assume aradially-compressed state and a radially-expanded state, (b) includes aframe and a covering fixed to the frame, and (c) when in theradially-expanded state, is generally orthogonal to the actuating shaftand has a greatest dimension, measured perpendicular to the actuatingshaft, of between 10 and 50 mm, and an orifice-support stent at leastpartially in the LAA, wherein the orifice-support stent is (a) fixed toand extending distally from the proximal LAA-orifice cover, (b)configured to assume a radially-compressed state and a radially-expandedstate, and (c) generally cylindrical when in the radially-expandedstate; inflating the compliant balloon by filling, via a fluid flow pathalong a portion of the actuating shaft, a fluid into the balloonchamber; expanding the balloon in a radial or a lateral direction byshortening the distance between the distal and the proximal end portionsof the balloon to a desired distance; and releasing the occlusion devicefrom the delivery system.
 93. The method according to claim 92, whereinthe orifice-support stent is not fixed to the balloon, such that a shapeof the balloon can change independently of a shape of theorifice-support stent.
 94. The method according to claim 92, whereininflating the compliant balloon transitions the orifice-support stentfrom its radially-compressed state to its radially-expanded state.
 95. Amethod for occluding a left atrial appendage (LAA) of a patient, themethod including: using a delivery system, positioning a compliantballoon of an occlusion device in a longitudinally extended form thereofin the LAA; inflating the compliant balloon by filling, via a fluid flowpath along a portion of an actuating shaft of the occlusion device, afluid into a fluid-tight balloon chamber defined by the balloon, while avalve of the occlusion device in an open state in which the valve allowsfluid flow between the fluid flow path and the balloon chamber, whereinthe actuating shaft is (a) disposed at least partially within theballoon chamber, (b) connected to a distal end portion of the balloon,and (c) longitudinally moveable with respect to a proximal end portionof the balloon so as to set a distance between the distal and theproximal end portions of the balloon; expanding the balloon in a radialor a lateral direction by shortening the distance between the distal andthe proximal end portions of the balloon to a desired distance, byproximally longitudinally moving the actuating shaft: (a) to a firstpredetermined distance between the distal and the proximal end portionsof the balloon, which automatically transitions the valve from the openstate to a closed state in which the valve blocks fluid flow between thefluid flow path and the balloon chamber, and (b) to a secondpredetermined distance between the distal and the proximal end portionsof the balloon, which automatically transitions a locking mechanism froman unlocked state to a locked state, in which the locking mechanismmaintains, between the distal end portion of the balloon and theproximal end portion of the balloon, the distance set using theactuating shaft; and releasing the occlusion device from the deliverysystem.
 96. The method according to claim 95, wherein positioning theballoon in the LAA comprises: advancing a guidewire into a body of thepatient using the delivery system; and advancing the occlusion deviceover the guidewire.
 97. The method according to claim 95, wherein thefirst predetermined distance does not equal the second predetermineddistance.
 98. The method according to claim 97, wherein the firstpredetermined distance is less than the second predetermined distance.99. The method according to claim 95, wherein the first predetermineddistance equals the second predetermined distance.
 100. The methodaccording to claim 95, wherein the occlusion device is shaped so as todefine the fluid flow path alongside the portion of the actuating shaft.101. The method according to claim 95, wherein the valve is disposedalong the actuating shaft.
 102. The method according to claim 95,wherein the occlusion device further comprises a proximal tube, which isaxially fixed with respect to the proximal end portion of the balloon,wherein the actuating shaft is slidably disposed partially within theproximal tube.
 103. The method according to claim 102, wherein theocclusion device is shaped so as to define the fluid flow path along theportion of the actuating shaft radially between an external surface ofthe actuating shaft and an internal surface of the proximal tube. 104.The method according to claim 103, wherein the valve is disposed alongthe actuating shaft.
 105. The method according to claim 104, wherein thevalve comprises a seal around at least a portion of the external surfaceof the actuating shaft, and wherein the valve is configured to assumethe open state when the seal is disposed at one or more first axialpositions with respect to the proximal tube, and the closed state whenthe seal is disposed at one or more second axial positions with respectto the proximal tube, the one or more second axial positions proximal tothe one or more first axial positions.
 106. The method according toclaim 105, wherein the seal, the actuating shaft, and the proximal tubeare arranged such that the seal blocks fluid flow out of a distal end ofthe proximal tube at least when the seal is disposed at the one or morefirst axial positions with respect to the proximal tube.
 107. The methodaccording to claim 103, wherein a wall of the proximal tube is shaped soas to define one or more tabs through the wall, wherein the one or moretabs are biased to flex radially inward, and wherein, when the valve isin the open state, the fluid flow path passes through the wall betweenrespective proximal ends of the one or more tabs and a non-tabbedportion of the wall axially adjacent the one or more tabs.
 108. Themethod according to claim 107, wherein the non-tabbed portion of thewall is disposed proximal to the one or more tabs.
 109. The methodaccording to claim 107, wherein the external surface of the actuatingshaft is shaped so as to define one or more protrusions around at leasta portion of the actuating shaft, and wherein the proximal ends of theone or more tabs are shaped so as to prevent distal movement of the oneor more protrusions when the one or more protrusions are disposedproximal to the proximal ends of the one or more tabs, thereby causingthe locking mechanism to assume the locked state.
 110. The methodaccording to claim 102, wherein the occlusion device further comprises aproximal LAA-orifice cover, which (a) is fixed to the proximal tuberadially surrounding the proximal tube, (b) is configured to assume aradially-compressed state and a radially-expanded state, (c) comprises aframe and a covering fixed to the frame, (d) when in theradially-expanded state, is generally orthogonal to the proximal tubeand has a greatest dimension, measured perpendicular to the proximaltube, of between 10 and 50 mm, and (e) is indirectly connected to theballoon via the proximal tube and is not directly connected to theballoon.
 111. The method according to claim 110, wherein the occlusiondevice further comprises an orifice-support stent, which (a) is fixed toand extends distally from the proximal LAA-orifice cover, (b) isconfigured to assume a radially-compressed state and a radially-expandedstate, and (c) is generally cylindrical when in the radially-expandedstate.
 112. The method according to claim 111, wherein theorifice-support stent, when in the radially-expanded state, has (i) agreatest dimension, measured perpendicular to the actuating shaft, ofbetween 8 and 50 mm, and (ii) an axial length of between 4 and 30 mm.113. The method according to claim 95, wherein the occlusion devicefurther comprises connecting struts fixed to the distal end portion ofthe balloon and to the proximal end portion of the balloon.
 114. Themethod according to claim 113, wherein the occlusion device isconfigured such that inflation of the balloon chamber plasticallydeforms the connecting struts.
 115. The method according to claim 113,wherein the occlusion device is configured such that shortening of theballoon plastically deforms the connecting struts.